nrsp-7 2004 i nrsp-7 mission statement the mission of nrsp-7 is: • to identify animal drug needs...

NRSP-7National Research Support Project No. 7

Annual Report

2004

The Minor Use Animal Drug Program

Agricultural ResearchersPharmaceutical ManufacturersAnimal ProducersUSDAFDA/CVMConsumers

http://www.nrsp7.org

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NRSP-7 Mission Statement

The mission of NRSP-7 is:• to identify animal drug needs for minor species and minor uses in

major species,• to generate and disseminate data for safe and effective therapeutic

applications, and• to facilitate FDA/CVM approvals for drugs identified as a priority for

a minor species or minor use.

To accomplish these goals, NRSP-7 functions through the coordination ofefforts among animal producers, pharmaceutical manufacturers, FDA/CVM,USDA/Cooperative State Research, Education, and Extension Service,universities, State Agricultural Experiment Stations and veterinary medicalcolleges throughout the country.

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Executive Summary

NRSP-7 has been responsible for 31 Public Master File (PMF) publications in theFederal Register, an average of 1.3 per year during its 23 years of funding. These PMFinvolved 14 animal species. Additionally, five data packages have been submitted forreview by the Center for Veterinary Medicine. Regional coordinators and members ofNRSP-7 were active in communicating to stakeholders through presentations and 15peer-reviewed publications.

To date 334 drug requests have been submitted to the Minor Use Animal DrugProgram for the development of data in support of the submission of a New Animal DrugApproval. Currently there are 13 active research projects involving 9 unique animalspecies and 11 different drugs. Approximately 23% of the active projects involveruminant species, 15% avian, 38% aquatic and 23% other species such as rabbits andhoney bees. While a majority of Public Master Files (53%) involved ruminant species,current active projects are more evenly divided among additional species.

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Table of Contents

Mission Statement iExecutive Summary ii

Statement of the Problem 1Justification and Stakeholders 2NRSP-7 Objectives 3Organization 3Funding 4Activities, Accomplishments, Interactions with Stakeholders and Communications 5

Northeastern Region 6North Central Region 7Southern Region 8Western Region 9

Publications 12

Table 1. Operation of NRSP-7 Following the Identification of Need Through Research,FDA/CVM Submission and Drug Approval

Table 2. Public Master Files (PMF) Published, New Animal Drug Approvals (NADA) andPending Approvals

Table 3. NRSP-7 Active Projects

Table 4. Potential NRSP-7 Projects

Appendix IAnimal Drug Requests Received by NRSP-7

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Project Number: NRSP-7

Project Title: NRSP-7 A National Agricultural Program to Approve Animal Drugs for MinorSpecies and Uses

Duration: October 1, 2002 – September 30, 2004

Statement of the ProblemIn 1976, the Food and Drug Administration (FDA initiated an extensive study of the

minor use of animal drugs through the efforts of a minor use/minor species drug committee.This committee, comprised of representatives of the FDA’s then Bureau of Veterinary Medicineand Bureau of Foods, the U.S. Department of Agriculture (USDA), the pharmaceutical industry,and animal producer groups identified the scope of the problem a lack of approved drugs for (1)diseases of minor species an (2) the principle minor diseases of major species. The committeeidentified the principal diseases for which drugs were not available in the minor species. Thecommittee also recognized that the livestock industry in the United States relies heavily on thejudicious use of drugs for the prevention and treatment of diseases in food animals. Withoutthese drugs, animal suffering and mortality would greatly increase, as would the cost ofproducing animal-derived food products. However, before a drug can be marketed for use in afood animal species, it must be shown to be safe to the human consumer of the animal-derivedfood, and safe and efficacious in the target animal.

The process of generating the safety and efficacy data necessary for FDA approval of adrug is costly and time-consuming. At present, the estimated cost to a pharmaceutical companyfor research necessary to obtain FDA approval for a new drug exceeds $20 million, and requires8 to 10 years of concentrated research effort. The addition of a new label claim is also costly,averaging $2 to $8 million. Because of this substantial investment in time and resources,pharmaceutical companies must be assured that the drug will have a reasonable potential forprofit. Therefore, most drug approvals are sought only for those animal species that areproduced in sufficient numbers to support large volume sales, specifically cattle, swine,chickens and turkeys. There is little economic incentive for pharmaceutical firms to generatedata necessary to seek FDA approval of drugs in minor species; hence, very few drugs areavailable for management of diseases in these species. Inequities in drug availability representserious management and economic problems for producers for minor species.

The FDA was aware that veterinarians and livestock producers were using unapproveddrugs without the safeguards that approved drugs carry. Such unapproved drug use could notonly cause detrimental effects to the animals being treated, but could also lead to thepersistence of drug residues in animal products intended for human consumption. A definiteneed was established for approval of minor use veterinary drugs and the scope of the problemwas defined. This need was also affirmed by various grower organizations.

In 1982, the IR-4 Animal Drug Program was established as part of the overall IR-4 MinorUse Pesticide Management Program. Since that time the animal portion established itself as anational means of securing approved drugs and as a conduit between the animal industries andthe FDA.

In December 1990, the USDA/CSRS requested a peer review of the IR-4 program,including both the pesticide portion and the minor use animal component. A reorganization of

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the minor use animal drug section was one of the recommendations of the Review Team. ThisChange was carried out with the development of a separate Minor Use Animal Drug TechnicalCommittee that reported to the IR-4 Administrative Advisors.

In 1992, IR-4 Administrative Advisors recommended that with the change frominterregional Projects (IR’s) to National Research Support Projects (NRSP’s), as well as theexperience gained under the reorganized IR-4 Project, that the two programs (pesticide andanimal) be separated into two projects. In 1993, NRSP-7 was thus created as the Minor UseAnimal Drug Program.

Justification and StakeholdersGross annual income from production of minor animal species has been estimated by

USDA at over $9 billion in the US. Production of aquatic species alone accounts for nearly $1billion in revenue, much of this isolated in one or two states. Revenues from processingeffectively triple the annual revenues produced by minor species in the US. While thecumulative contribution of minor species to agricultural income is great, the return topharmaceutical companies for research on therapeutics is small and generally unprofitable.Since 1964, private sponsors have approved the use of drugs for this need as follows: none forrabbits, one for ducks and pheasants (none for other game birds), two for food fish, four forgoats and twenty-one for sheep. Minor and specialty use needs have continued to accumulate,leaving the producer of these species without the drugs necessary for disease prevention andcontrol. More than 41 drug-species combinations are identified as urgently in need of approvalfor minor species (Table 5). Research at State and Federal Laboratories to provide datanecessary for such approval will be provided through the Minor Use Animal Drug Program.

The Animal and Plant Health Inspection Service (APHIS) recently reported that 9.4% ofthe lambs born alive died before weaning and that death losses in adult sheep during 1995 were5.1% of inventory. With 7.8 million sheep and lambs in inventory in 1997, this loss is significantin dollar value. These are but two examples of agricultural losses due to disease and the impacton farm income. There is no total dollar value loss for all minor species as the result of diseasesbut has been estimated to be in the billions of dollars. Additionally it should be born in mind thegoat industry is growing. Despite this, approval of drugs for use in these animals by the Foodand Drug Administration (FDA) has been greatly hampered by increased regulatoryrequirements and increased costs of drug development. The full implementation of the AnimalMedicinal Drug Uses Clarification Act [AMDUCA] and the Animal Drug Approval Act [ADAA]have produced new orders of priorities in drugs for minor species. Additionally in the past 12months the Congress has considered bills to promote drug availability for minor uses in majorspecies and for minor species. This “MUMS Bill” was introduced in both houses but, in theevents following the September terrorist attacks, languished and will have to come up again inthe new session. This bill will give significant incentives to Pharmaceutical Manufacturers towork for drug approvals in the MUMS arena as well provide grant funds that the NRSP-7regions may well compete for.

The limitations imposed by AMDUCA on extra-label drug use in feeds proved to be amajor problem to aquaculture and gamebird industries and a guidance document has outlinedconditions where limited extralabel use of approved formulations will be permitted underconditions of a valid veterinarian-client-patient relationship. The Minor Use Animal DrugProgram is the only organized State/Federal effort to address the inadequate number of FDAapproved drugs available for minor-use species and has been responsible for nearly all of the

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progress made in the approval of minor-use/minor-species drugs. The history of the program isthat prior to October 1, 1993, the Minor Use Animal Drug Program operated as a part of the IR-4program. At that time it was separated from the plant orientated IR-4 and re-established as theNational Research Support Project 7 (NRSP-7) for the Minor Use Animal Drug Program. It isnow in it’s second cycle of Congressional approval.

Federal regulations require an extensive examination of experimental data on efficacy,safety, and residue depletion before any drug can be used in a food animal species. Datamust also be obtained for each animal species for which drug use is intended. At present,most minor species of food animals do not have the benefit of safe and effective drugs suchas are available for cattle, swine and poultry. This situation has the potential to cause adverseeffects upon both the producers and consumers of animal products.

NRSP-7 Objectives

1. Identify the animal drugs for minor species and minor uses in major species.2. Generate and disseminate data for the safe, effective, and legal use of drugs intended

for use in minor animal species.3. Facilitate FDA/CVM approvals of drugs for minor species and minor uses.

Minor uses include minor species (all species except dogs, cats, horses, cattle, swine,chickens, turkeys) and minor uses in major species are those that occur infrequently or inlimited geographical locations. The primary emphasis of The Program will be on food-and/orfiber- (hair, wool, fur, feathers or hide) producing minor species.

OrganizationNRSP-7 is composed of a Technical Committee and four Administrative Advisors

representing State Experiment Station Directors. These Administrative Advisors provide liaisonbetween the Directors of the State Experiment Stations, USDA/CSREES, FDA/CVM, variousanimal organizations, and others coordinating the efforts of this program. The AdministrativeAdvisors provide input on policy, budget and administrative matters.

The organizational structure of the Minor Use Drug program follows:Administrative Advisory CommitteeThe Administrative Advisory Committee is composed of one Experiment Station Director

from each of the four regions (North Central, Northeast, Southern, and Western). The chair ofthe committee is selected internally. The role of the Administrative Advisory Committee is toprovide liaison between the Directors of the Agricultural Experiment Stations in the four regions,Colleges of Veterinary Medicine, the USDA/CSREES, the FDA/CVM, various animalorganizations, and with those coordinating the efforts of this program. This committee willestablish and set policy consistent with the mission of this project. This committee will alsoadvise on budget and administrative matters relating to this program.

Technical CommitteeThe Technical Committee is composed of the following representatives:

• National Animal Drug Coordinator (Chair)• Regional Animal Drug Coordinators representing each of the four regions (North

Central, Northeast, Southern, and Western)

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• Administrative Advisory Committee Chair (non-voting)• USDA/CSREES Representative (non-voting)• FDA/CVM liaison to NRSP-7 (non-voting)

In addition to the above committee, the FDA/CVM has a Minor Use Animal Drug Committeethat meets with the Technical Committee generally once a year at the semi-annual meetings ofthe Technical Committee. This FDA committee consists of representatives from the Division ofTherapeutic Drugs for Food Animals, Antimicrobial Drugs Branch, Methods Validation andAnalytical Branch, Companion and Wildlife Drugs Branch, and the Environmental SciencesStaff. The National Animal Drug Coordinator is salaried on a part-time basis and maintains anoffice. The Regional Animal Drug Coordinators are not compensated by salary except forsecretarial or technical services.

Cooperating Agencies and Principal Leaders:US Department of Agriculture/CRESS

Dr. Larry R. Miller USDA/CRESS Representative

US Food and Drug Administration/Center for Veterinary MedicineDr. Meg R. Oeller FDA/CVM Liaison

Administrative AdvisorsDr. Donald. C. Robertson (Chair) Kansas AESDr. Kirklyn M. Kerr Connecticut AESDr. David Thawley Nevada AESDr. Gary Adams Texas AES

National CoordinatorDr. John G. Babish New York AES

Regional CoordinatorsDr. Arthur L. Craigmill California AESDr. Paul R. Bowser New York AESDr. Alistair I. Webb Florida AESDr. Ronald W. Griffith Iowa AES

FundingThe Minor Use Animal Drug Program is funded through USDA Special Research Grant,

administered by CSREES in cooperation with the NRSP-7 Technical Committee. Currently,there are no “off-the-top” Regional Research funds allocated to the Minor Use Program. Theprogram receives significant “in-kind support from several sources including the institutionsconducting the research (State Agriculture Experiment Stations, Colleges of VeterinaryMedicine, Federal laboratories), animal producer groups through contributions of animals forresearch, and pharmaceutical companies. Perhaps the most significant of this “in-kind” supportcomes through the cooperation of the pharmaceutical companies, which provide access to theirproprietary data package prepared for the drug approval in a major species. In addition, thepharmaceutical sponsors complete the approval package by adding the new use of the drug totheir current label, and often contribute to the program in the form for drug research, as well asdirect financial aid. Without the generous support of the pharmaceutical manufactures, thisprogram would not be possible.

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The Regional Animal Coordinators are not compensated by salary for time contributed tothe Minor Use Program. In some cases, secretarial and/or technical support services arebudgeted from the Program. Funding is provided for the National Drug Coordinator’s part-timesalary and the maintenance of an office.

In the 23 years of the minor species drug program, a total of $9.6 million has beengranted through federal funding and an additional 41 percent, on average, has been obtainedthrough nonfederal funds. The average total expenditure per completed research for a drugapproval or publication of a Public Master File was $398,000. This figure includes fivesubmissions currently under review at FDA/CVM as well as the Public Master Files listed inTable 2. Average federal expenditures per completed research for a drug approval orpublication of a Public Master File was $304,000.

Activities, Accomplishments, Interactions with Stakeholders and CommunicationsPrior to the Minor Animal Drug Approval Program, the FDA had approved the use of drugs

for minor species as follows: none for rabbits, one for ducks and pheasants (none for other gamebirds), two for food fish, four for goats and twenty-one for sheep. Minor and specialty use needshave continued to accumulate, leaving the producer of these species without the drugs necessaryfor disease prevention and control. More than 100 drugs have been identified as urgently in needof approval for minor species. The Minor Use Animal Drug Program has received 334 AnimalDrug Requests submitted by researcher investigators at federal, state, and university laboratories,veterinarians, and animal industry personnel for approval of a specific drug for the control of acertain disease in an animal industry. Each request is reviewed on basis of need and research isscheduled for selected projects as outlined in Table 1.

Since the first drug approval in 1984 a total of 31 Public Master Files [PMF] have beenpublished in the Federal Register (Table 2), an average of 1.3 per year during its twenty-threeyears of funding (Table 2). These PMF involved 14 animal species. Thus, 31 drugs have gainedapproval through this program, nearly trebling the number approved for all minor species andminor uses when this program was initiated. Additionally, five data packages have beensubmitted for review by the Center for Veterinary Medicine. Regional coordinators and membersof NRSP-7 were active in communicating to stakeholders through presentations and 15 peer-reviewed publications.

Currently there are 13 active research projects involving 9 unique animal species and 11different drugs (Table 3). Approximately 23% of the active projects involve ruminant species,15% avian, 38% aquatic and 23% other species such as rabbits and honey bees. While amajority of Public Master Files (53%) involved ruminant species, current active projects aremore evenly divided among additional species.

Objective 1Identify the critical needs of the various producers of minor livestock species

The Staff of the Southern Region represented NRSP-7 at the AVMA's annual meeting inBoston last July and at the North American Veterinary Conference in Orlando early this year.The Southern Region has taken responsibility for the NRSP-7 Home-Page [www.nrsp-7.org].This resulted in reworking the public sector and, the IP limited access site [“Ringer Site”] whichcontinues to allow members of the committee access to archival data, relevant media material,

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and information on on-going projects. The latter includes an ASP interactive database [“MUMSRx”], which will complete development in the current year and be available for public access.

During the last two years, drug coordinators and the FDA liaison commenced regularteleconferences. These have been coordinated by the PI of the Southern Region and haveproved very successful in facilitating communication and coordination between the partiesparticipating. This usually takes place at 1100 hours EST on the first Monday of the month.

Objectives 2 and 3Generate and disseminate data for the safe, effective, and legal use of drugs used primarily in

therapy or reproductive management of minor animal species.Facilitate FDA/CVM approvals of drugs for minor species and minor uses.

NRSP-7 has been responsible for 31 Public Master File (PMF) publications in theFederal Register, an average of 1.3 per year during its 23 years of funding. These PMFinvolved 14 animal species. Additionally, five data packages have been submitted for review bythe Center for Veterinary Medicine. Regional coordinators and members of NRSP-7 were activein communicating to stakeholders through presentations and 15 peer-reviewed publications.

Currently there are 13 active research projects involving 9 unique animal species and 11different drugs. Approximately 23% of the active projects involve ruminant species, 15% avian,38% aquatic and 23% other species such as rabbits and honey bees. While a majority of PublicMaster Files (53%) involved ruminant species, current active projects are more evenly dividedamong additional species.

Regional coordinators and members of NRSP-7 were active in communicating tostakeholders through presentations and 15 peer-reviewed publications.

To date 334 drug requests have been submitted to the Minor Use Animal Drug Programfor the development of data in support of the submission of a New Animal Drug Approval.Through a prioritization process that has included (i) constraints imposed by concerns ofantimicrobial resistance, (ii) limitations of availability of certain expensive or rare animal species,(iii) appropriate efficacy models, and (iv) high risk/benefit liabilities and lack of economicincentive for certain pharmaceutical manufacturers, the number of highest priority projects hasbeen estimated at approximately 41 (Table 4). Added to our 13 current active projects, thebacklog of projects represents a research commitment stretching over several decades.

Program Activity By regionNortheast RegionHydrogen Peroxide for Treatment of Bacterial Gill Disease in Fish. (INAD 9493)

All target animal safety studies have been performed for rainbow trout and walleye.Final reports and manuscripts for publication have either been published or in review forpublication.

Human Food Safety Studies of Oxytetracycline in Fish. (INAD 10-319)Human food safety/tissue elimination kinetics studies of oxytetracycline have beencompleted in tilapia (25C, 30C), walleye (15C, 20C), summer flounder (17C, 20C), andhybrid striped bass (20C, 25C). All tissues samples have been processed and several

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manuscripts based on this comparative pharmacokinetics study have been submitted forpublication in the peer reviewed literature.

Human Food Safety Studies of Romet-30 in Fish. (INAD 10-823)Human food safety/tissue elimination kinetics studies of Romet-30 have been completed

in tilapia (25C, 30C), summer flounder (17C, 20C), and walleye (20C, 25C). All tissues sampleshave been processed and data have been analyzed. Human food safety/tissue eliminationkinetics studies of Romet-30 were initiated in hybrid striped bass at 20C. Problems wereexperienced with a lack of palatability of the medicated feed by the hybrid striped bass. In spiteof several attempts to circumvent this palatability problem, no solution to this problem could befound. We have recently learned that the manufacturer has developed a means ofcircumventing the palatability problem with this therapeutant. As a result, we anticipateperforming human food safety trials with the modified Romet-30 product.

Rofenaid in pheasants. (INAD 10-804)A Target Animal Safety study of Rofenaid in Pheasants has been completed. Currently,statistical analyses is underway for the data describing body weight, body weight gain, feedconsumption and feed efficiency. Small differences were observed in weight gain at the end ofthe experimental period (28 days), in favor of the groups fed Rofenaid at 5X the normalconcentration. A problem was encountered with background lesions in the population of birdsused for the study. As a result, the Target Animal Safety Study will be repeated. Birds will beobtained from a different source and grown under laboratory conditions until they are used. Webelieve this will eliminate the problem encountered in the initial trial.

North Central RegionA project to determine the pharmacokinetics of Tilmicosin in veal calves was terminated

at the request of the manufacturer. Protocols for this project have been approved by FDA/CVMand the project could be activated at the request of the manufacturer. A project was initiatedwith Dr. Dennis Hallford at New Mexico State University to perform tissue residue studies withthe CIDR-G. The in-life phase of the study was performed in November and December 2003.The NRSP-7 North Central and Western region programs cooperated with Dr. Hallford tocomplete the in-life phase. The analytical phase of the CIDR-G project is progressing andpreliminary reports have been received from Dr. Hallford. A project to determine thepharmacokinetics of florfenicol in veal-age calves received FDA/CVM approval in July, 2003.The in-life phase intramuscular dosing route for this project has been completed and the serumsamples submitted to Dr. Art Craigmill, University of California, Davis to perform analyticalassays. The in-life phase subcutaneous dosing route was complicated by the presence ofdisease in the calves and is currently scheduled to be repeated. A opinion on whether datafrom healthy calves in the subcutaneous dosing route study can be combined with data from asecond experiment has been requested from FDA/CVM. In addition to the pharmacokineticstudies, the manufacturer of Nuflor (florfenicol) requested that NRSP-7 perform the TargetAnimal Safety and Injection Site Irritation studies in veal calves. Protocols for these studieshave been submitted to FDA/CVM for review. The North Central Region is supporting a projectin cooperation with Dr. Hank Harris, Iowa State University to determine efficacy of florfenicol(Aquaflor) for treatment of necrotizing hepatopancreatitis in shrimp. The protocols for this studyare nearing completion and should be ready to submit to the FDA/CVM soon. A request fromproducer groups to explore two other drugs has been received by the North Central Region.These projects are for lasalocid in pheasants and growth-promoting implants in veal calves.

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Southern RegionLast year the manufacturer of Micotil® [Elanco] used the Public Master File [PMF]

developed by the Southern Region to facilitate their successful submission to FDA/CVM to adda claim for sheep respiratory disease to their label. The Southern Region will be working withthe same company towards an approval for tilmicosin in pre-ruminating calves. This work willbe done in collaboration with the Central Region where Dr. Griffith has expertise in infectiousdiseases.

All in-life work has been completed for the tissue depletion and target animal safety[TAS] work for the fenbendazole in gamebirds approval [ADR 280 INAD 10-062] and theremaining validation in quail tissue is nearing completion at the Western Region. The targetanimal studies report was not considered satisfactory and is being re-written by the SouthernRegion instead.

The human food residues studies for ivermectin in rabbits [ADR 107/141] is beingrepeated at the Southern Region as the UCD laboratory was unable to process the samples in atimely manner. The delay that would be caused by having to evaluate freezer stability wouldplace this project too late in the FDA approval cycle. The Southern Region will be able to usethis duplication in the training of the biological scientist to be hired. In view of this we have goneahead and completed the target animal safety packet and are in the process of submitting it toFDA/CVM without waiting further for the tissue depletion work to be completed. The assay ofivermectin that had proved troublesome has finally been mastered by Southern Region’schemist and validation is underway. It is planned to cross validate the method with beef tissuesas that was the species that the method was originally developed for.

Efficacy trials for zoalene [a coccidiostat] and nitarsone [an anti-histomoniasis drug] ingamebirds continue to be on hold until a investigator to do laboratory infection studies has beenidentified. To avoid these coordination problems in the future, the Southern Region has hired abiological scientist to coordinate these on-site trials and to personally supervise critical stages.That person is also undergoing training in GLP study management and quality control.

It is anticipated by the manufacturer that zoalene will have a zero withdrawal should thisproduct be labeled for game birds. For this, target tissue has to have zoalene concentrationsbelow the FDA tolerance set for turkey [the major species the approval is being based on].Those studies have been conducted at the Southern Region in the Clinical Pharmacologylaboratory of the PI. The analyses were complicated in that the zoalene is degraded in freezingto ANOT [a zoalene derivative] and no standard was obtainable for that. The laboratory had tomake the ANOT, have it's identity confirmed by GC and then validate the analysis. This hasbeen re-submitted to CVM/FDA.

Although it is classed as a production drug, [aid in spawning], the administrative work forcrude carp pituitary extract is being handled by the Southern Region. The literature review tosupport the efficacy claims of crude carp pituitary extract has been submitted to FDA/CVMwhere it was augmented by the FDA Liaison. The initial target animal safety study wascompleted by Dr. Anita Kelly at Mississippi State University and her report submitted. Furtherwork has been carried out this past spawning season to expand the TAS study to cover funnedfish. The report is pending but there is concern that the manufacturer has withdrawn from theproject citing FDA audit problems. A new manufacturer is being sought.

Work has continued on developing protocols and recruiting collaborators for studies oflasalocid [a coccidiostat] in non-lactating goats and farmed deer. The manufacturer has beenvery active in assisting in this project development and will be conducting the tissue and feedanalyses. The Efficacy Protocol has been reviewed by FDA/CVM and is under revision at thistime.

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The Staff of the Southern Region represented NRSP-7 at the AVMA's annual meeting inDenver last July and at the North American Veterinary Conference in Orlando early this year.

The Southern Region continues being responsible for the NRSP-7 Home-Page[www.nrsp-7.org] and the IP limited access site [“Ringer Site”] which continues to allowmembers of the committee access to archival data, relevant media material, and information onon-going projects. The latter includes an ASP interactive database [“MUMS Rx”] which wascompleted in the past year and is available for public access. Work is underway to develop aninteractive project tracking system [Regional Update System Tracking Information – RUSTi].The prototype was praised during the recent program review conducted by a CSREESappointed team. RUSTi will be mounted on the Ringer site.

During the last year the drug coordinators and the FDA liaison conducted regularteleconferences. These have been coordinated by the PI of the Southern Region and continuedto be very successful in facilitating communication and coordination between the partiesparticipating. These conference usually take place at 1130 hours EST on the first Monday ofthe month.

Summary• Elanco label extension for tilmicosin for respiratory diseases in sheep applied for and

approved.• All in vivo work on fenbendazole target animal safety and tissue depletion in game birds

completed.• Representation of program at National and Regional meetings.• Continued development of NRSP-7 web site.• Originated and developed an on-line project tracking program [RUSTi]

Western RegionDuring 2003, the primary accomplishments were:

Florfenicol in sheep (ADR #325): The final report „Pharmacokinetics of Nuflor® inSheep‰ was submitted to FDA/CVM for review. Human food safety was completed and thetissues are currently undergoing analyses.

Progesterone CIDRs for sheep (ADR #258): The target animal safety portion wascompleted and the final report is in preparation.

Fenbendazole in game birds ADR#280: (collaborative project with the SouthernRegion): Method validation has been completed and the final report is in preparation. „Residuesof Fenbendazole in Game Birds‰ was presented as an abstract at the 2003 Society ofToxicology meeting.

Romet-30 in fish (ADR#313) (collaborative project with the North East Region) TheWestern region laboratory has completed the sample analyses. The data are currently beingevaluated.

Ceftiofur in llamas and alpacas (ADR #275): Publication of „Pharmacokinetics ofCeftiofur in Llamas and Alpacas‰ has been accepted for publication in the Journal ofVeterinary Pharmacology and Toxicology (JVPT).

Ceftiofur/Red Deer (ADR #251): Publication of „Pharmacokinetics of Ceftiofur in RedDeer‰ has been accepted for publication in the Journal of Veterinary Pharmacology andToxicology (JVPT).

Lincomycin/Bees (ADR #311): Target animal safety report has been accepted byFDA/CVM.

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Tylosin/Bees (ADR #217): Target animal and human food safety portions have beencompleted and reviewed by FDA/CVM.

Species Grouping: Comparative metabolism studies continue. Preliminary results werepresented at the 2003 SOT meeting. The findings from all of these studies will be utilized to fulfill the data requirements for theFDA/CVM approval of drugs for use in minor species.

Work planned for next year:The completion of the projects above is the primary work planned for next year, together

with continued research on species grouping for avian species. All of these findings have beenor will be used to gain FDA/CVM approval of these drugs for use in the respective minorspecies, which will be of great benefit to producers and veterinarians.

Current work:Projects cleared

ADR# 8 Albendazole for treatment of adult liver flukes in non-lactating goats.(Washington, California)

ADR #11 Ivermectin for treatment of warbles in reindeer. (Alaska, California)ADR #87 Amoxicillin for treatment of bacterial pneumonia in sheep. (Idaho, California)ADR #111 Decoquinate for treatment of coccidiosis in goats. (Washington, California)ADR #127 Fenbendazole for treatment of lungworms in bighorn sheep. (Washington,

California)ADR #169 Formalin for the treatment of protozoal infections of marine penaeid shrimp.

(Arizona, California)ADR #170 Naxcel® Sterile Powder (Ceftiofur) for the treatment of respiratory disease in

sheep. (California)ADR #171 Naxcel® Sterile Powder (Ceftiofur) for treatment of bacterial pneumonia in

goats. (California, Idaho)

Research completed—Public Master files in preparationADR #135 Erythromycin to treat bacterial kidney disease in salmonids. (Idaho,

California)ADR #176 Amoxicillin for use in lactating dairy goats. This project is combined with

ADR #33 to cover lactating goats. Milk residue study completed and submitted April 1991.(California)

Completed projectsADR #43 Oxytetracycline for the treatment of respiratory disease in goats. The efficacy

and target animal safety studies are completed. A milk residue depletion study was conductedin 1999 and the report was submitted to CVM February 2000. A paper on the pharmacokineticsand residues in meat and milk was published in the Journal of Veterinary Pharmacology andTherapeutics, 25(25-32), 2002. (California, Idaho, New York)

ADR #83 Oxytetracycline to treat respiratory disease in sheep. The results of thisresearch have been published in the Journal of Veterinary Pharmacology and Therapeutics.

ADR #199 Enrofloxacin for the treatment of vibriosis in shrimp. The data needed bythe investigator for the final report were received in 1994, however the final report was notacceptable and was never addressed by the investigator. (Arizona, California)

ADR #222 Ivermectin for the treatment of gastrointestinal parasites in American bison.Our laboratory has completed the serum and tissue residue analyses and these results were

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added to the final report and submitted in 1999. The Human Food Safety and Target AnimalSafety technical reports were submitted to CVM in August 1999 and CVM responded in July2000 requesting more information. A follow-up freezer stability study should be completed thisyear. (California, Michigan)

ADR #251 Ceftiofur for the treatment of respiratory diseases in red deer. Publication of„Pharmacokinetics of Ceftiofur in Red Deer‰ has been accepted for publication in the Journalof Veterinary Pharmacology and Toxicology (JVPT).

ADR #261 Ceftiofur for the treatment of respiratory diseases for psittacine birds.Pharmacia & Upjohn, Inc. have provided funding for this project. (Preliminary studies haveshown equivalent levels in serum to other species (sheep) but more rapid elimination.) Theresearch has resulted in a publication, however despite support from the sponsor for the study,they will not support further work to add psittacines to the product label, thus this project iscomplete.

ADR #275 Ceftiofur sodium (Naxcel®) for the treatment of respiratory infections inllamas and alpacas. Publication of „Pharmacokinetics of Ceftiofur in Llamas and Alpacas‰ hasbeen accepted for publication in the Journal of Veterinary Pharmacology and Toxicology(JVPT). The project was only partially funded by the NRSP-7 project. (Collaborative project withthe Southern Region)

ADR #284 MGAGnRH for estrus synchronization and out-of-season breeding in sheep.Our laboratory director provided GLP assistance for this project in March of 1998. A preliminaryreport from Idaho indicates that the researcher was not able to show that MGA induced out-of-season breeding. (Idaho/California)

Active projectsADR #107 Ivermectin to treat ear mites in rabbits. Analysis was postponed due to

continuing difficulties with recovery and interfering peaks. The tissue residue samples are morethan two years old and will need to be redone and will be analyzed by the southern region.(Florida, California)

ADR #217 Tylosin to control American Foulbrood in bees. Target animal and humanfood safety portions have been completed and reviewed by FDA/CVM

ADR #258 Progesterone CIDRs for sheep. The target animal safety portion wascompleted and the final report is in preparation.

ADR #270 Amoxicillin for the treatment of respiratory diseases in striped bass. Whilethis project remains on the active list for the region, there has been no activity to report for thelast year. (California)

ADR #280 Fenbendazole for the treatment of gastrointestinal parasites in game birds.(Collaborative project with the Southern Region): Method validation has been completed andthe final report is in preparation. „Residues of Fenbendazole in Game Birds‰ was presented asan abstract at the 2003 Society of Toxicology meeting.

ADR #295 Strontium chloride for use as a marking agent in salmonids. The investigatorhas been contacted and is in the process of assembling a report on project activities.(California/Alaska)

ADR #299 Pirlimycin to treat mastitis in dairy goats. Pharmacia supports this projectand we will submit the necessary protocols to FDA/CVM this year. (California)

ADR #311 Lincomycin to treat American Foulbrood in honey bees. The Target animalsafety report has been accepted by FDA/CVM.

ADR #313 Romet-30 in fish. (Collaborative project with the North East Region) TheWestern region laboratory has completed the sample analyses. The data are currently beingevaluated.

NRSP-7 2004

-12-

ADRs #325 Florfenicol for sheep and goats. The final report „Pharmacokinetics ofNuflor® in Sheep‰ was submitted to FDA/CVM for review. Human food safety was completedand the tissues are currently undergoing analyses.

Potential future projectsADR #302 Various antibiotics to treat bacterial infections in shellfish. (California,

Washington)ADR #324 CIDR for estrus synchronization in goats.

Continuation projects and new projects will be considered at the Animal Drug SpringMeeting in 2004.

The completion of the Minor Use Animal Drug projects mentioned above entail intensivesample collections and sample analyses. Analytical method implementation and validation mustbe done for each drug for each species. Thousands of serum and tissue samples wereanalyzed by High Performance Liquid Chromatography (HPLC) for the ceftiofur project alone.These HPLC analyses were labor intensive and expensive, however, the data generated underGLP's will satisfy the FDA/CVM requirements.

Progress on all projects undertaken is slow, but steady, and the number of projectscompleted stands as proof to the effectiveness of the program.

Publications1. Wang J, Gehring R, Baynes RE, Webb AI, Whitford C, Payne MA, Fitzgerald K, Craigmill

AL, Riviere JE. Evaluation of the advisory services provided by the Food Animal ResidueAvoidance Databank. J Am Vet Med Assoc 2003;223:1596-8.

2. Mehl ML, Kyles AE, Craigmill AL, Epstein S, Gregory CR. Disposition of cyclosporineafter intravenous and multi-dose oral administration in cats. J Vet Pharmacol Ther2003;26:349-54.

3. Bowser PR, Wooster GA, Chen CY, Mo RS. Polymicrobic infection of hybrid striped bass(Morone chrysops x Morone saxatilis) with three bacterial pathogens: a case report. JFish Dis 2004;27:123-7.

4. Drew ML, Johnson L, Pugh D, Navarre CB, Taylor IT, Craigmill AL. Pharmacokinetics ofceftiofur in llamas and alpacas. J Vet Pharmacol Ther 2004;27:13-20.

5. Drew ML, Waldrup K, Kreeger T, Craigmill AL, Wetzlich SE, Mackintosh C.Pharmacokinetics of ceftiofur in red deer (Cervus elaphus). J Vet Pharmacol Ther2004;27:7-11.

6. Gehring R, Baynes RE, Craigmill AL, Riviere JE. Feasibility of using half-life multipliersto estimate extended withdrawal intervals following the extralabel use of drugs in food-producing animals. J Food Prot 2004;67:555-60.

7. Haskell SR, Payne MA, Webb AI, Riviere JE, Craigmill AL. Current approved drugs foraquatic species. J Am Vet Med Assoc 2004;224:50-1.

8. Lane VM, Wetzlich S, Clifford A, Taylor I, Craigmill AL. Intravenous and subcutaneouspharmacokinetics of florfenicol in sheep. J Vet Pharmacol Ther 2004;27:191-6.

9. Webb AI, Baynes RE, Craigmill AL, Riviere JE, Haskell SR. Drugs approved for smallruminants. J Am Vet Med Assoc 2004;224:520-3.

10. Benson KG, Tell LA, Young LA, Wetzlich S, Craigmill AL. Pharmacokinetics of ceftiofursodium after intramuscular or subcutaneous administration in green iguanas (Iguanaiguana). Am J Vet Res 2003;64:1278-82.

NRSP-7 2004

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11. Craigmill AL. A physiologically based pharmacokinetic model for oxytetracyclineresidues in sheep. J Vet Pharmacol Ther 2003;26:55-63.

12. Downer J, Craigmill A, Holstege D. Toxic potential of oleander derived compost andvegetables grown with oleander soil amendments. Vet Hum Toxicol 2003;45:219-21.

13. Fielding CL, Magdesian KG, Elliott DA, Craigmill AL, Wilson WD, Carlson GP.Pharmacokinetics and clinical utility of sodium bromide (NaBr) as an estimator ofextracellular fluid volume in horses. J Vet Intern Med 2003;17:213-7.

14. Haskell SR, Gehring R, Payne MA, Craigmill AL, Webb AI, Baynes RE, Riviere JE.Update on FARAD food animal drug withholding recommendations. J Am Vet MedAssoc 2003;223:1277-8.

15. Kyles AE, Gregory CR, Craigmill AL, Griffey SM, Jackson J, Stanley SD.Pharmacokinetics of tacrolimus after multidose oral administration and efficacy in theprevention of allograft rejection in cats with renal transplants. Am J Vet Res2003;64:926-34.

NRSP-7 2004

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Submitted:

John G. Babish, Ph.D. DateNational CoordinatorChair, Technical Committee

Donald C. Robertson, Ph.D. DateChair, Administrative Advisors

NRSP-7 2004

NRSP-7 2004

Table 2. Public Master Files (PMF) Published, New Animal Drug Approvals (NADA) andPending Approvals

Drug Formulation Species Indication

Albendazole Oral suspension Goats Liver flukesAmoxicillin trihydrate Injectable Sheep Bacterial pneumoniaAmprolium Premix Pheasants CoccidiosisBacitracin Premix Quail Ulcerative enteritisCeftiofur Injectable Sheep Bacterial pneumoniaCeftiofur Injectable Goats Bacterial pneumoniaCIDR† Intravaginal Goats Estrus synchronization

Clorsulon Oral suspension Goats Liver flukesDeccox† Premix Pheasants & partridges CoccidiosisDecoquinate Premix Sheep CoccidiosisDecoquinate Premix Goats CoccidiosisFenbendazole Oral suspension Goats GI parasitesFenbendazole Premix Bighorn sheep LungwormsFlorfenicol Oral Shrimp Necrotizing pancreatitis

Formalin Oral soluble powder Penaeid shrimp External protozoan parasitesFormalin Topical soluble powder Finfish and eggs External fungal & protozoan parasitesIvermectin Injectable Reindeer WarblesIvermectin Injectable Goats GI parasitesIvermectin Injectable Fox Ear mitesIvermectin Injectable American bison HypodermosisIvermectin† Injectable Emu Nematodes, lice, mitesLasalocid Premix Rabbits CoccidiosisLasalocid Premix Chukar partridges CoccidiosisLevamisole Oral soluble powder Goats G.I. parasitesMonensin Premix Goats CoccidiosisMonensin Premix Quail CoccidiosisMonensin sodium† Premix Pheasants & partridges CoccidiosisMorantel tartrate Premix Goats GI parasitesOxytetracycline Premix Lobster GaffkemiaOxytetracycline Immersion Various fish Otolith markingOxytetracycline† Oral Abalone Withering syndrome

Salinomycin Premix Quail CoccidiosisSulfadimethoxine /ormetoprim Premix Catfish Bacterial infectionsSulfadimethoxine /ormetoprim Premix Chukar partridges CoccidiosisThiabendazole Premix Pheasants GapewormTilmicosin phosphate Injectable Sheep Chronic respiratory

†Pending

NRSP-7 2004

Table 3. NRSP-7 Active Projects


Erythromycin Premix Salmonids Bacterial kidney diseaseFenbendazole Premix Pheasants & partridges Gapeworm & capillariaFlorfenicol Injection Sheep Respiratory infections

Hydrogen peroxide Topical Various fish Bacterial gill diseaseIvermectin Injectable Rabbits Ear mitesIvermectin Pour-on American bison GI parasitesLincomycin Soluble powder Bees American FoulbroodOxytetracycline Feed Various fish VibriosisPirlimycin Intramammary Goats Mastitis

Progesterone CIDR Sheep Estrus synchronizationStrontium Chloride Immersion Fish Otolith markingSulfadimethoxine & ormetoprim Premix Pheasants Bacterial infection & coccidiosisSulfadimethoxine & ormetoprim Premix Fish Bacterial infections

NRSP-7 2004

Table 4. Potential NRSP-7 Projects


Amoxicillin Premix Salmonids FurunculosisAmoxicillin Premix Hybrid striped bass Strep infectionsAmoxicillin Injectable Dairy goats(lactating) Bacterial pneumoniaCeftiofur Injectable Rabbits PasteurellosisCeftiofur Injectable Red deer Respiratory infectionsCIDR Intravaginal Goats Estrus synchronization

Clopidol Premix Pheasant CoccidiosisCopper sulfate Topical soluble powder Channel catfish External protozoa Deccox Premix Pheasants CoccidiosisDeccox Premix Partridges CoccidiosisErythromycin Premix/ injectable Salmonids Bacterial kidney disease Fenbendazole Premix Fallow deer GI parasitesFlorfenicol Injectable Sheep Foot rotFlorfenicol Injectable Goats Respiratory infectionsFlorfenicol Injectable Goats Foot rotFlorfenicol Oral Shrimp Necrotizing pancreatitis

Hydrogen peroxide Topical Atlantic salmon Sea liceIvermectin Pour-on Red deer GI parasites and lungwormIvermectin Pour-on American bison GI parasitesIvermectin Injectable Emu Nematodes, lice, mitesLasalocid Premix Pheasant CoccidiosisLasalocid Premix Deer CoccidiosisLasalocid Oral Goats Coccidiosis

MGA/GnRH Feed/injectable Sheep Estrus synchronizationMonensin sodium Premix Pheasants CoccidiosisMonensin sodium Premix Partridges CoccidiosisNitarsone Premix Partridge BlackheadNovobiocin/ penicillin Intramammary infusion Dairy goats MastitisOxytetracycline Premix Alligators Bacterial infectionOxytetracycline Injectable Dairy goats (nonlactating) Bacterial pneumoniaOxytetracycline Injectable Sheep Bacterial pneumoniaOxytetracycline Oral Abalone Withering syndromePirlimycin Intramammary Goats Mastitis

Potassium permanganate Topical Catfish External ichthyophthirius multifilisPraziquantel Premix/oral capsule Wild ducks SchistosomiasisPraziquantel Premix/oral capsule Geese SchistosomiasisPraziquantel Premix/oral capsule Mute swan SchistosomiasisSpectinomycin Injectable/oral soluble powder Ducks Colibacillosis, salmonellosisSulfadimethoxine/ormetoprim Premix Pheasants Bacterial infection & coccidiosisSulfamethazine Oral sustained release tablets Sheep Bacterial pneumoniaZoamix Premix Pheasants Coccidiosis

NRSP-7 2004

Appendix I

NRSP-7 2004

Appendix I Page 1

ADR Date rec'd Drug Formulation Species Indication Firm Reg

1 Feb-82 Monensin premix goats coccidiosis Elanco S2 Apr-82 Amprolium premix pheasants coccidiosis Merial NE3 Nov-81 Monensin premix sheep coccidiosis Elanco NC

4 Jun-82Sulfadimethoxine/ ormetoprim

premix catfish bacterial infections Alpharma S

5 Apr-84 Thiabendazole premix pheasants gapeworm Merial NE

6 Nov-82 BHTpremix/ unspecified topical

fish viral diseases —— W

7 Oct-82Various coccidiostats & antibiotics

—— rabbitscoccidiosis, pasteurellosis

—— HQ

8 Dec-82 Albendazole oral suspension goats liver flukes Pfizer W9 Dec-82 Lincomycin premix ducks pasteurellosis Pharmacia NE

10 Dec-82 Penicillin premix ducks erysipelas Fort Dodge NE11 Sep-81 Ivermectin injectable reindeer warbles Merial W

12 Jul-83 Fenbendazoleoral suspension/ premix

goats GI parasites Intervet NC

13 Jan-83 Monensin premix cattle emphysema Elanco HQ14 Jan-83 Decoquinate premix sheep coccidiosis Alpharma S15 Oct-83 Oxytetracycline premix lobster gaffkemia Phibro NE16 Feb-83 Xylazine injectable goats anesthesia Bayer NC17 Jan-83 Ivermectin injectable goats GI parasites Merial

18 Jun-84 Chloramine-Ttopical soluble powder

salmonids bacterial gill disease Accentive NC

19 Dec-83 Oxytetracycline premix alligators bacterial infection Phibro S

20 Jul-84 Chloramine-Ttopical soluble powder

catfish bacterial infection Accentive S

21 Dec-82 Albendazole oral suspension sheep liver flukes Pfizer NC22 Aug-84 Penicillin injectable ducks erysipelas Pfizer NC23 Apr-83 Lutalyse injectable goats anestrus Pharmacia S24 Apr-83 Monensin premix goats coccidiosis Elanco S25 May-83 Xylazine injectable cattle anesthetic Bayer S26 Jun-83 Mebendazole oral paste goats GI parasites Schering S

27 May-83 Spectinomycinintramammary infusion

cattle mastitis Bimeda S

28 Oct-83 Chloramine-Ttopical soluble powder

salmonidsexternal bacterial infections

Natchez W

29 Oct-83 Lasalocid premix goats coccidiosis Alpharma W30 Oct-83 Bacitracin premix quail ulcerative enteritis Alpharma S

31 Nov-83 Praziquantelpremix/ oral capsule

wild ducks, geese, mute swan

schistosomiasis Bayer NC

32 Dec-83 Ampicillin oral bolus goats enteritis Fort Dodge W

33 Dec-83 Amoxicillin trihydrate injectabledairy goats (nonlactating)

bacterial pneumonia Pfizer W

34 Dec-83 Amoxicillin trihydrate oral bolusdairy goats (nonlactating)

bacterial enteritis Pfizer W

35 Dec-83 Amoxicillin trihydrate oral bolusdairy goats (nonlactating)

bacterial enteritis Pfizer W

36 Dec-83 Ampicillin injectabledairy goats (lactating)

bacterial pneumonia Fort Dodge W

37 Dec-83 Ampicillin injectabledairy goats (nonlactating)

bacterial pneumonia & enteritis

Fort Dodge W

38 Dec-83 Ampicillin oral bolusdairy goats (nonlactating)

enteritis Fort Dodge W

39 Dec-83 Chlortetracycline premixdairy goats (nonlactating)

bacterial infections Alpharma W

40 Dec-83 Chlortetracycline premix dairy goats bacterial pneumonia Alpharma W

41 Dec-83 Neomycin sulfateoral soluble powder

dairy goats (nonlactating)

enteritis Pharmacia W

42 Dec-83 Oxytetracyclineinjectable (100 mg/ml)


bacterial infections Pfizer W

NRSP-7 2004

Appendix I Page 2


43 Dec-83 Oxytetracycline injectabledairy goats (nonlactating)


44 Dec-83 Oxytetracyclineinjectable (long acting)



45 Dec-83 Oxytetracyclineinjectable (50 mg/ml)



46 Dec-83 Benzathine penicillin injectable dairy goats bacterial pneumonia Fort Dodge W47 Dec-83 Procaine Penicillin injectable dairy goats bacterial infections Fort Dodge W48 Dec-83 Sulfachloropyridazine oral powder dairy goats enteritis Fort Dodge W49 Dec-83 Sulfachloropyridazine injectable dairy goats enteritis Fort Dodge W50 Dec-83 Sulfabromomethazine oral bolus dairy goats bacterial infections Merial W51 Dec-83 Sulfachloropyridazine oral bolus dairy goats enteritis Fort Dodge W

52 Dec-83 Sulfadimethoxineoral drinking water solution

dairy goats bacterial pneumonia Alpharma W

53 Dec-83 Sulfadimethoxine oral bolus? dairy goats bacterial pneumonia Alpharma W54 Dec-83 Sulfadimethoxine oral powder dairy goats bacterial pneumonia Alpharma W55 Dec-83 Sulfadimethoxine oral powder dairy goats bacterial pneumonia Alpharma W

56 Dec-83 Sulfaethoxypyridazine injectable dairy goats bacterial infectionsAmerican Cyanamid

W

57 Dec-83 Sulfaethoxy- pyridazineoral drinking water solution

dairy goats bacterial infectionsAmerican Cyanamid

W

58 Dec-83 Sulfaethoxy- pyridazine oral bolus dairy goats bacterial infectionsAmerican Cyanamid

W

59 Dec-83 Sulfamethazineoral sustained release tablets

goats bacterial pneumonia Bayer W

60 Dec-83 Oxytetracycline injectable goats enteritis Pharmacia W61 Dec-83 Tylosin injectable goats bacterial pneumonia Elanco W

62 Jan-84 Benzathine cloxacillinintramammary infusion

dairy goats mastitis Pfizer W

63 Jan-84Benzathine cloxacillin (Dry-Clox)

intramammary infusion


64 Jan-84 Cephapirin benzathineintramammary infusion

dairy goats mastitis Fort Dodge W

65 Jan-84 Novobiocinintramammary infusion

dairy goats mastitis Pharmacia W

66 Jan-84 Novobiocin/ penicillinintramammary infusion

dairy goats mastitis Pharmacia W

67 Jan-84 Hetacillinintramammary infusion

goats mastitis Fort Dodge W

68 Jan-84 Sodium cepharinintramammary infusion

goats mastitis Fort Dodge W

69 Jan-84 Sodium cloxacillinintramammary infusion

goats mastitis Pfizer W

70 Jan-84Dimethyl benzyl ammonium chloride

immersion brown trout bacterial gill disease —— NE

71 Jan-84Dimethyl benzyl ammonium chloride


72 Feb-84 Diquat immersion brown trout bacterial gill disease Chevron NE73 Feb-84 Furazolidone premix trout furunculosis Fort Dodge NE

74 Feb-84 Sulfamethazineoral sustained release tablets

sheep bacterial pneumonia Bayer NE

75 Feb-84Dimethyl benzyl ammonium chloride


NRSP-7 2004

Appendix I Page 3


77 Mar-84Clinoprost tromethamine??

injectable sheepbreeding synchronization

Pharmacia W

78 Mar-84 Ivermectin sheep G.I. parasites Merial W79 Mar-84 Lasalocid premix sheep coccidiosis Alpharma W

80 Mar-84 LevamisoleOral soluble powder

sheep G.I. parasitesAmerican Cyanamid

W

81 Mar-84 Monensin premix sheep coccidiosis Elanco W

82 Mar-84 Norgesterone injectable sheep estrus synchronization Bimeda W

83 Mar-84 Oxytetracycline injectable sheep bacterial pneumonia PfizerW & NC

84 Mar-84 Spectinomycininjectable/oral soluble powder

sheep colibacillosis Bimeda W

85 Mar-84 Tylosin premix sheepMycoplasma pneumonia

Elanco W

86 Mar-84 Progesterone injectable sheep anestrus —— NC87 Apr-84 Amoxicillin trihydrate injectable sheep bacterial pneumonia Pfizer W88 Apr-84 Ampicillin injectable sheep bacterial pneumonia Pfizer W89 Apr-84 Virginiamycin premix rabbits bacterial infections Phibro W90 May-84 Monensin premix quail coccidiosis Elanco S

91 May-84 Erythromycin premix quailchronic respiratory disease

Abbott Labs S

92 May-84 Ipronidazole oral quail blackhead Alpharma S93 May-84 Isoxsuprine HCl Oral tablets horse navicular disease Bimeda S94 May-84 Di-N-Butyl Tin Oxide immersion channel catfish tapeworms M & T S

95 May-84 LevamisoleOral soluble powder

goats G.I. parasites Schering NE

96 May-84Sulfadimethoxine /ormetoprim

premix catfish bacterial infections Alpharma S

97 May-84Tricaine methanesulfonate

topical solution salmonids anesthetic Argent Labs S

98 Aug-84 LevamisoleOral soluble powder

sheep G.I. parasites Schering NE

99 Aug-84 Sulfaquinoxaline premix pheasants coccidiosis Merial S

100 May-84 Mebendazoleoral soluble powder

goats G.I. parasites Schering S

101 May-84 Methylene blue injectable cattle nitrate poisoning Hanford NE

102 May-84Erythromycin thiocyanate

premix mink enteritis Bimeda NC

103 Aug-84 Griseofulvinoral soluble powder

rabbits ringworm Schering NE

104 Aug-84 Monensin premix rabbits coccidiosis Elanco NE105 Aug-84 Procaine penicillin injectable rabbits pasteurellosis Pfizer NE106 Aug-84 Azaperone injectable wild ungulates immobilization Schering NE107 Sep-84 Ivermectin injectable rabbits ear mites Merial S

108 Sep-84 Chlortetracycline injectable rabbits pasteurellosisAmerican Cyanamid

S

109 Sep-84Sulfadimethoxine /ormetoprim

premix rabbits hepatic coccidiosis Alpharma S

110 Sep-84 Ivermectin Injectable fox ear mites Merial S111 Sep-84 Decoquinate premix goats coccidiosis Alpharma NE112 Nov-84 Clorsulon oral suspension goats liver flukes Merial S

113 Nov-84 Amproliumoral soluble powder/ premix

quail coccidiosis Merial NE

114 Nov-84 Monensin premix quail coccidiosis Elanco NE115 Nov-84 Salinomycin premix quail coccidiosis Alpharma NE116 Dec-84 Phenylbutazone oral bolus? sheep arthritis Schering NE117 Dec-84 Lasalocid premix goats coccidiosis Alpharma S118 Jan-85 Tiamulin premix trout red mouth disease Boehringer NE

NRSP-7 2004

Appendix I Page 4


119 Jan-85 Sodium fluoride premix salmonidsbacterial kidney disease

—— NE

120 Feb-85 Oxolinic acid premix salmonids furunculosis, vibriosis Parke-Davis W

121 May-85 Amoxicillinintramammary infusion


122 May-85 Lasalocid premix rabbits coccidiosis Alpharma S123 Oct-85 Botram 75 W soluble powder bees foulbrood —— W124 Jan-86 Fenbendazole oral suspension goats GI parasites Intervet NC125 Jul-85 Ivermectin injectable Am. bison hypodermosis Merial NC126 Oct-85 Clorsulon oral suspension sheep liver flukes Merial NE127 Nov-85 Fenbendazole premix bighorn sheep lungworms Intervet W

128 Dec-85 Amproliumoral drinking water solution

swine (neonates) coccidiosis Merial S

129 Jan-86 LevamisoleOral soluble powder

quail endoparasites Schering S

130 Jan-86 Chlorine dioxide topical solution salmonidsfurunculosis, bacterial gill disease

—— NE

131 Feb-86 Benzocainetopical soluble powder

salmonids anesthesia —— NC

132 Mar-86 Melatonin premix sheep anestrus —— NC133 Mar-86 Lactic acid injectable sheep (lambs) chemical castration Boehringer NE

134 Mar-86 Levamisoleoral soluble powder

goats GI parasites Schering NE

135 Jul-86 Erythromycin premix salmonidsbacterial kidney disease

Bimeda W

136 Aug-86Sulfadimethoxine /ormetoprim

premix quail coccidiosis Alpharma NE

137 Aug-86Sulfadimethoxine /ormetoprim

premix chukar partridges coccidiosis Alpharma NE

138 Oct-86 Virginiamycin premix alligatorshatchling alligator syndrome

Phibro S

139 Nov-86 Ivermectin injectable cattle ticks Merial S

140 Feb-87 Amproliumoral soluble powder premix

rabbits coccidiosis Merial W

141 Feb-87 Ivermectin injectable rabbits ear mites Merial NE142 Feb-87 Oxytetracycline premix rabbits bacterial infections Phibro W143 Jan-87 Lasalocid premix rabbits coccidiosis Alpharma W144 Sep-87 Morantel tartrate premix goats GI parasites Phibro S145 Sep-87 Enrofloxacin premix salmonids furunculosis Bayer NE

146 Sep-87 Enrofloxacin premix salmonidsbacterial kidney disease

Bayer NE

147 Oct-87 Ivermectininjectable/oral suspension

mink GI parasites Merial NC

148 Oct-87 Amproliumoral soluble powder/ premix

mink coccidiosis Merial NC

149 Oct-87 Sulfathiazoleoral soluble powder

mink bacterial enteritis Fort Dodge NC

150 Oct-87 Sulfadimethoxinewsp/tablets/ oral suspension

minkcoccidiosis, resp. and UT infections

Schering NC

151 Oct-87 Ivermectininjectable/oral suspension

foxes GI parasites Merial NC

152 Oct-87 Amproliumsoluble powder/ premix

foxes coccidiosis Merial NC

153 Oct-87 Sulfathiazole soluble powder foxes bacterial enteritis Fort Dodge NC

154 Oct-87 Sulfadimethoxineoral soluble powder/tablets/oral suspension

foxescoccidiosis, resp. and UT infections

Schering NC

155 Oct-87 Ivermectin injectable fishexternal crustacean and internal nematode parasites

Merial W

NRSP-7 2004

Appendix I Page 5


156 Oct-87 Praziquantel premix/ injectable fishcestodes and trematodes

Bayer W

157 Nov-87 Ivermectin injectable ranch foxes ear mites Merial NC

158 Nov-87Tricaine methanesulfonate

topical soluble powder

striped bass anesthesia Argent S

159 Nov-87Sulfadimethoxine /ormetoprim

premix striped bass bacterial infections Alpharma S

160 Nov-87 Formalin topical solution striped bassexternal protozoan parasites

Argent S

161 Nov-87 Oxytetracycline premix striped bass pasteurellosis Phibro S

162 Mar-88Fumagillin dicyclohexylamine

premix/ injectable salmonidsproliferative kidney disease

Abbott W

163 Mar-88 Fenbendazole premix pheasants gapeworm Intervet W164 Mar-88 Morantel tartrate premix/oral bolus sheep GI parasites Phibro W165 Mar-88 Ceftiofur injectable sheep bacterial pneumonia Pharmacia W166 Mar-88 Ceftiofur injectable goats bacterial pneumonia Pharmacia W

167 Apr-88Lincomycin/spectinomycin

oral soluble powder

quail air sacculitis Pharmacia S

168 Apr-88 Fenbendazoleoral soluble powder

quail GI parasites Intervet S

169 Jun-88 Formalinoral soluble powder

penaeid shrimpExternal protozoan parasites

Argent W

170 Feb-89 Ceftiofur injectable sheep bacterial pneumonia Pharmacia W

171 Feb-89 Ceftiofur injectable goats bacterial pneumonia PharmaciaW & NC

172 Feb-89 Zinc bacitracin premix rabbits post-weaning enteritis Schering W

173 Mar-89Ethylenedinitrilo tetraacetic acid copper

injectable sheep copper deficiencyVeterinary Research & Development

W

174 Mar-89 Erythromycin premix/ injectable salmonidsbacterial kidney disease

Bimeda W

175 Apr-89 Enrofloxacin premix American eelsAeromonas salmonicida infections

Bayer S

176 May-89Amoxicillin (keep w/ 33)

injectabledairy goats (lactating)


177 May-89 Enrofloxacinoral drinking water solution

rabbits pasteurellosis Bayer NE

178 Sep-89 Spectinomycininjectable/oral soluble powder

duckscolibacillosis, salmonellosis

Pharmacia NC

179 Dec-89PD 127391 (fluoroquinolone)

oral drinking water solution

cockatiels psittacosis Fort Dodge NE

180 Oct-89 Ceftiofur intrauterine dairy cattle metritis Pharmacia W181 Nov-89 Morantel tartrate premix/oral bolus sheep GI parasites Phibro S182 Nov-89 Albendazole premix/block white tailed deer meningeal worm Intervet NC183 Nov-89 Metaclopramide implant cattle fescue toxicosis A.H. Robins S

184 Apr-90PD 117,596 (fluoroquinolone)

premix salmonids furunculosis Fort Dodge NE

185 May-90 Fenbendazole premix/feed block white tailed deer meningeal worm Intervet NC

186 May-90Sodium carbonate peroxyhydrate


channel catfishexternal protozoan parasites

—— S

187 May-90Avermectin (Moxidectin)

biobullet implant bighorn sheepscabies, GI parasites, lungworm

Wildlife Labs W

188 May-90Avermectin (Moxidectin)

biobullet implant deerGI parasites, external parasites

Wildlife Labs W

NRSP-7 2004

Appendix I Page 6


189 Jun-90 Sulfathiazole premix minkbacterial pneumonia (Pseudomonas)

Boehringer NC

190 Jul-90 Ceftiofur biobullet implant bighorn sheep bacterial pneumonia Pharmacia W191 Aug-90 Lasalocid premix chukar partridges coccidiosis Alpharma NE

192 Aug-90Ethylene vinyl acetate copolymer

pellet bait binder lobsters, crabs bait binder DuPont NE

193 Oct-90 Sarafloxacin premix alligatorshatchling alligator syndrome

Abbott S

194 Nov-90 Cephapirinintramammary infusion

dairy goats mastitis Fort Dodge S

195 Nov-90 Ivermectin premix bighorn sheep scabies Merial W196 Feb-91 Ivermectin pour-on llamas GI parasites Merial W

197 Feb-91 Ivermectin pour-on red deerGI parasites and lungworm

Merial W

198 Apr-91 Ceftiofur injectable rabbits pasteurellosis Pharmacia W199 Mar-91 Enrofloxacin soluble powder penaeid shrimp bacterial infections Bayer W

200 Mar-91 Erythromycinsoluble powder/premix

penaeid shrimp bacterial infections Bimeda W

201 Mar-91 Trichlorfon soluble powder channel catfish insect predation Bayer S

202 Feb-91 Ivermectin/ Clorsulon injectable llamasGI parasites, liver flukes

Merial W

203 Feb-91 Enrofloxacin premix striped bass bacterial infections Bayer S

204 Oct-91 Nitrofurazonetopical soluble powder

shrimp bacterial infections Argent Labs S

205 Oct-91 Coppertopical solution (concentrate)

shrimp bacterial infections Argent Labs S

206 Nov-91 Albendazole premix/feed block white tail deer meningeal worm Pfizer NC

207 Dec-91 Captantopical soluble powder

sheep club lamb fungus Drexel Chemical NC

208 Dec-91 Trifluralintopical solution (concentrate)

shrimp mycosis Elanco W

209 Jan-92 Amoxicillin premix salmonids furunculosis —— W

210 Mar-92Fenbendazole (216 active)

premix red deer G.I. parasites Intervet S

211 Mar-92 Ivermectin blocks bighorn sheep psoroptic mange Merial W212 Apr-92 Metaclopramide oral bolus cattle fescue toxicosis —— S213 Apr-92 Sarafloxacin premix striped bass septicemia Abbott S

214 Apr-92 Enrofloxacin premix hybrid striped bass columnaris disease Bayer S

215 Apr-92 Sarafloxacin premix channel catfishenteric septicemia and motile Aeromonas septicemia

Abbott S

216 May-92 Fenbendazole premix fallow deer GI parasites Intervet S

217 May-92 Tylosin soluble powder honey bees foul brood Elanco W218 Sep-92 Phenothiazine block/pellet/ liquid sheep, goats GI parasites Schering NE

219 Sep-92N,N'-bis-(dichloroacetyl)-1-8 octane diamine

premix timber wolvesantispermatogenic contraceptive

Sterling NC

220 Nov-92 Oxytetracycline premix Chinook salmoncolumnaris disease, vibriosis

Phibro W

221 Nov-92 Oxytetracycline premix white sea basscolumnaris disease, vibriosis

Phibro W

222 Nov-92 Ivermectin pour-on American bison GI parasites Merial NC

NRSP-7 2004

Appendix I Page 7


223 Dec-92 Ceftiofur injectable goats bacterial pneumonia Pharmacia S224 Dec-92 Procaine penicillin G injectable goats bacterial pneumonia Pfizer S225 Dec-92 Erythromycin injectable goats bacterial pneumonia Bimeda S226 Dec-92 Tylosin injectable goats bacterial pneumonia Elanco S227 Dec-92 Sulfadimethoxine injectable goats bacterial pneumonia Alpharma S228 Jan-93 Ceftiofur injectable veal calves respiratory infections Pharmacia NC

229 Jan-93 Zinc bacitracin premix veal calvesenteric disorders, feed efficiency

Alpharma NC

230 Jan-93 Ivermectinsustained release oral bolus

reindeer warbles Merial W

231 Feb-93 Copper sulfatetopical soluble powder

channel catfish external protozoa —— S

232 Mar-93Human chorionic gonadotropin

injectablestriped bass, white bass, hybrid striped bass

spawning aid Intervet S

233 Mar-93 Enrofloxacin injectable ducks

colibacillosis, salmonellosis, pasteurellosis (anatipestifer)

Bayer NC

234 Jun-93Luteinizing hormone releasing hormone analog

injectable various fish spawning aid —— W

235 Jul-93 Lasalocid premix pheasant coccidiosis Alpharma NC

236 Jul-93 Clopidol premix pheasant coccidiosis Aventis NC

237 Aug-93 Ivermectin water gamebirds GI parasites Merial NC

238 Sep-93 Formalintopical soluble powder

Finfish and eggsExternal fungal & protozoan parasites

Argent W

239 Sep-93 Carp Pituitary injectable White Sturgeon spawning aid Stoller W

240 Sep-93Potassium permanganate


White SturgeonExternal fungal & protozoan parasites

Carus Chemical W

241 Sep-93 Oxytetracycline premix White Sturgeon Internal bacterial Phibro W242 Sep-93 Oxytetracycline immersion White Sturgeon External bacterial Pfizer W243 Sep-93 Sarafloxacin premix White Sturgeon Internal bacterial Abbott W

244 Sep-93 Oxytetracycline premix various fishotolith marking columnaris

Phibro NC

245 Sep-93 Oxytetracycline immersion various fish otolith marking Pfizer NC246 Sep-93 Tilmicosin phosphate injectable sheep chronic respiratory Elanco S

247 Oct-93 Diminazene aceturate injectable cattleanaplasmosis piroplasmosis

Intervet S

248 Dec-93 Spectinomycin injectable veal calf enteric colibacillosis Fort Dodge NC249 Aug-94 Oxytetracycline injectable veal calf respiratory inf Pfizer NC

250 Feb-94 Levamisole phosphate injectable bisonGI parasites Ostertagia

Schering NC

251 Aug-94 Ceftiofur injectable red deer respiratory inf Pharmacia W

252 Aug-94 Tilmicosin phosphate injectable veal calf respiratory inf Elanco NC

253 Aug-94 Fenbendazole premix bison GI parasites Intervet S254 Aug-94 Clopidol premix rabbit coccidiosis Aventis NC255 Jan-95 Salinomycin rabbit coccidiosis Alpharma NC

256 Jan-95Sulfadimethoxine & ormetoprim

premix rabbit coccidiosis Intervet NC

257 Mar-95 Oxytetracycline soluble powder lobster gaffkemia Pfizer NE

NRSP-7 2004

Appendix I Page 8


258 Mar-95 Progesterone CIDR sheep estrus synchronization Pharmacia NC/W

259 Apr-95 Hydrogen peroxide topical various fish bacterial gill disease Eko Nobel NE260 Apr-95 Hydrogen peroxide topical Atlantic salmon sea lice Eko Nobel NE261 May-95 Ceftiofur injectable psittacine birds gram-negative inf Pharmacia W262 Jun-95 Monensin premix rabbits coccidiosis Elanco NC

263 Oct-95 Erythromycin premix hybrid striped bass strep infections Bimeda W

264 Jan-96 Albendazole premix Emu nem/trem/cest Intervet S265 Jan-96 Ceftiofur injectable Emu bacterial infection Pharmacia S

266 Jan-96 Ivermectin injectable Emu nematodes, lice, mites Merial S

267 Jan-96 Sarafloxacin WSP Emu bacterial infection Abbot S

268 Jan-96 Sulfadimethoxine soluble powder Emubacterial infection & coccidiosis

Pfizer S

269 Jan-96 Sarafloxacin premix catfish Enteric septicemia Abbott W

270 Mar-96 Amoxicillin premix hybrid striped bass strep infections W

271 Apr-96 Carp Pituitary injectable various fish spawning aid Stoller fisheries S

272 Jul-96Sulfadimethoxine & ormetoprim

premix pheasantsbacterial infection & coccidiosis

Alpharma NE

273 Jul-96 Nitarsone premix partridge blackhead Alpharma S

274 Jul-96 Zoamix premix pheasantsgrowth, feed eff & coccidiosis

Alpharma S

275 Jul-96 Ceftiofur sodium injectablellamas, alpaca, fallow deer

respiratory infection Pharmacia W/S

276 Jul-96 Fenbendazole premix Ostrich & Emu nematodes Intervet S

277 Jul-96Potassium permanganate

topical catfishExternal ichthyophthirius multifilis

Carus Chemical S

278 Aug-96 Monensin sodium premixpheasants & partridges

coccidiosis Elanco S

279 Aug-96 Lasalocid premix pheasants coccidiosis Alpharma NC

280 Aug-96 Fenbendazole premixpheasants & partridges

gapeworm & capillaria Intervet S

281 Aug-96 Deccox premixpheasants & partridges

coccidiosis Alpharma S

282 Aug-96 Chlortetracycline premixpheasants & partridges

bacterial infections Alpharma NC

283 May-97 Oxytetracycline HCl soluble powderwalleye (larval fish)

columnaris Pfizer NE

284 Jun-97 MGA/GnRH feed/ injectable sheep estrus synchronizationPharmacia/ Fort Dodge

W

285 Nov-97 Oxytetracycline feed various fish vibriosis Phibro NE286 Nov-97 Oxytetracycline feed tilapia strep infections Phibro NE287 Feb-98 Ketamine injectable ostrich/emu anesthetic Fort Dodge W288 Feb-98 Xylazine injectable ostrich/emu sedative Bayer W289 Feb-98 Enrofloxacin WSP ostrich/emu bacterial infections Bayer W

290 Feb-98Trimethoprim/ Sulfadiazine

oral ostrich/emu bacterial infections Schering W

291 Jul-97 Ivermectin oral bait deer GI parasites Merial S292 Aug-97 Doxycycline extruded feed psittacines Chlamydia Kaytee NC293 Mar-98 Imexon Injectable mink Alleutian disease Boehringer W294 Sep-98 Lasalocid premix deer coccidiosis Alpharma S

295 Sep-98 Strontium Chloride immersion fish otolith markingWestern Chemical

W

296 Nov-98 Molybdate injectable sheep copper toxicity ? NC

NRSP-7 2004

Appendix I Page 9


297 May-99 Triclabendazole drench deer/elk liver flukes Novartis NC298 May-99 Lasalocid oral goats coccidiosis Alpharma S299 Aug-99 Pirlimycin intramammary goats mastitis Pharmacia W300 Aug-99 Moxidectin topical cage birds mites face/airsac Fort Dodge S301 Feb-00 Decoquinate in milk calves cryptosporidiosis Alpharma W302 Mar-00 Antimicrobials immersion shellfish bacterial infection ? W303 Apr-00 Banamine injection veal calves anti inflammatory Schering NC304 Apr-00 Neomycin 325 soluble powder veal calves bacterial enteritis Osborne NC305 Apr-00 Chlortetracycline soluble powder veal calves bacterial enteritis Fort Dodge NC306 Apr-00 Mu Se (selenium) injection veal calves Se deficiency Schering NC307 Apr-00 Florfenicol injection veal calves bacterial pneumonia Schering NC308 Apr-00 Micotil injection veal calves bacterial pneumonia Elanco NC

309 Apr-00 Sulfamethoxazole/trimethoprim 960

oral - tablets veal calves bacterial infections ? NC

310 Apr-00 Cephalexin oral veal calves bacterial infections ? NC311 May-00 Lincomycin soluble powder bees American Foulbrood Pharmacia W

312 Jun-00 Imidocarb injection dairy cattleanaplasmosis babesiosis

Schering S

313 Oct-00Sulfadimethoxine & ormetoprim

premix fish bacterial infections Alpharma NE

314 Oct-00 Tripelennamine HCl injection veal calves Antihistamine Fort Dodge NC315 Oct-00 Amikacin injection veal calves Diarrhea Fort Dodge NC316 Oct-00 Sulfachlor- pyridazine injection or oral veal calves Diarrhea Fort Dodge NC317 Oct-00 Levamisole phosphate injection veal calves GI parasites Schering NC

318 Oct-00 Penicillin injection veal calves bacterial infections Fort Dodge NC319 Oct-00 Chlortetracycline oral veal calves respiratory infections Alpharma NC320 Oct-00 Tylosin injection veal calves respiratory infections Elanco NC321 Oct-00 Apramycin oral veal calves Diarrhea Elanco NC322 Oct-00 Sulfadimethoxine injection or oral veal calves respiratory infections Pfizer NC323 Oct-00 Various products various veal calves various various NC324 Jan-01 CIDR intravaginal goats estrus synchronization Pharmacia W

325 Jul-01 Florfenicol injection sheep respiratory infections Schering W326 Jul-01 Florfenicol injection sheep foot rot Schering W327 Jul-01 Florfenicol injection goats respiratory infections Schering W328 Jul-01 Florfenicol injection goats foot rot Schering W329 Oct-01 Florfenicol injection veal calves respiratory infections Schering NC

330 Oct-01 Apitol patties honey bees Varroa mites Wellmark NC331 Mar-02 Arecoline (Cestolin) oral tablets gamebirds, pet

birds, cocksTapeworms, ascarids, trichinosis

Wallance Pharmaceut.

S

332 Oct-02 Oxytetracycline Oral abalone withering syndrome Phibro W333 Dec-02 Florfenicol Oral shrimp necrotizing pancreatitis Schering NC

334 Jun-03 Florfenicol Oral finfish bacterial infection Schering NE

nrsp-7 2004 i nrsp-7 mission statement the mission of nrsp-7 is: • to identify animal drug needs...

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