2018 fda approvals summary - pharmacircle.com...testosterone enanthate suutaneous solution antares...
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2018 FDA Approvals Summary
BLA, NDA, & Tentative Approvals
Key Drug-Device Supplements
PharmaCircle LLC
2019-01-14
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval
Date Marketing
Status Application
Category Indication
FDA Drugs Division - 2018 BLA Approvals (351(a) Biologics)
125294 GRANIX TBO-FILGRASTIM INJECTION INJECTABLE RATIOPHARM 2018-07-31 RX 351(a) Neutropenia
761051 POTELIGEO MOGAMULIZUMAB-KPKC INJECTION INJECTABLE KYOWA KIRIN 2018-08-08 RX 351(a) Mycosis Fungoides
761063 EMGALITY GALCANEZUMAB-GNLM INJECTION INJECTABLE ELI LILLY 2018-09-27 RX 351(a) Migraine
761065 TROGARZO IBALIZUMAB-UIYK INJECTION INJECTABLE TAIMED 2018-03-06 RX 351(a) Infections, HIV/AIDS, Other
761067 ILUMYA TILDRAKIZUMAB-ASMN INJECTION INJECTABLE SUN GLOBAL 2018-03-20 RX 351(a) Psoriasis, Other
761068 CRYSVITA BUROSUMAB-TWZA INJECTION INJECTABLE ULTRAGENYX 2018-04-17 RX 351(a) X-Linked Hypophosphatemia
761077 AIMOVIG ERENUMAB-AOOE INJECTION INJECTABLE AMGEN 2018-05-17 RX 351(a) Migraine
761079 PALYNZIQ PEGVALIASE-PQPZ INJECTION INJECTABLE BIOMARIN 2018-05-24 RX 351(a) Phenylketonuria
761089 AJOVY FREMANEZUMAB-VFRM INJECTION INJECTABLE TEVA 2018-09-14 RX 351(a) Migraine
761090 TAKHZYRO LANADELUMAB (SHP643) INJECTION INJECTABLE DYAX 2018-08-23 RX 351(a) Angioedema, Hereditary, Other
761092 REVCOVI ELAPEGADEMASE-LVLR INJECTION INJECTABLE LEADIANT 2018-10-05 RX 351(a) SCID, Other
761094 OXERVATE CENEGERMIN-BKBJ OPHTHALMIC SOLUTION DOMPE 2018-08-22 RX 351(a) Eye Diseases, Corneal
761097 LIBTAYO CEMIPLIMAB-RWLC INTRAVENOUS INJECTABLE REGENERON 2018-09-28 RX 351(a) Cancer, SCC
761102 ASPARLAS CALASPARGASE PEGOL-MKNL
INTRAVENOUS INJECTABLE SERVIER 2018-12-20 RX 351(a) Cancer, ALL
761104 LUMOXITI MOXETUMOMAB PASUDOTOX-TDFK
INJECTION INJECTABLE ASTRAZENECA 2018-09-13 RX 351(a) Cancer, HCL
761107 GAMIFANT EMAPALUMAB-LZSG INJECTION INJECTABLE NOVIMMUNE 2018-11-20 RX 351(a) Blood Cell Disorders, Other
761108 ULTOMIRIS RAVULIZUMAB-CWVZ INJECTION INJECTABLE ALEXION 2018-12-21 RX 351(a) PNH
761116 ELZONRIS TAGRAXOFUSP-ERZS INJECTION SOLUTION STEMLINE 2018-12-21 RX 351(a) Cancer, BPDCN
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 BLA Approvals (351(k) Biologics)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval
Date Marketing
Status Application
Category Indication
125545 RETACRIT EPOETIN ALFA-EPBX INJECTION INJECTABLE HOSPIRA 2018-05-15 RX 351(k) Anemia, Cancer/Chemo-Induced
761039 UDENYCA PEGFILGRASTIM-CBQV INJECTION INJECTABLE COHERUS 2018-11-02 RX 351(k) Neutropenia
761075 FULPHILA PEGFILGRASTIM-JMDB INJECTION INJECTABLE MYLAN 2018-06-04 RX 351(k) Neutropenia
761080 NIVESTYM FILGRASTIM-AAFI INJECTION INJECTABLE HOSPIRA 2018-07-20 RX 351(k) Neutropenia
761071 HYRIMOZ ADALIMUMAB-ADAZ INJECTION INJECTABLE SANDOZ 2018-10-30 RX 351(k) Psoriasis, Other
761088 TRUXIMA RITUXIMAB-ABBS INJECTION INJECTABLE CELLTRION 2018-11-28 RX 351(k) Cancer, NHL, Other
761091 HERZUMA TRASTUZUMAB-PKRB INJECTION INJECTABLE CELLTRION 2018-12-14 RX 351(k) Cancer, Breast, Other
All Rights Reserved - PharmaCircle LLC (2019)
FDA Vaccines, Blood & Biologics Division - 2018 BLA Approvals (351(a) Biologics)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
125586 ANDEXXA ANDEXANET ALFA INJECTION INJECTABLE PORTOLA 2018-05-03 RX 351(a) Hemostasis
125563 VAXELIS VAXELIS INJECTION INJECTABLE SANOFI
PASTEUR 2018-12-26 RX 351(a)
Infections, Diphtheria, Pertus-sis, Poliomyelitis, Haemophilus, Hepatitis B, Tetanus
125587 PANZYGA IMMUNOGLOBULIN G, HU-
MAN PLASMA-DERIVED INJECTION INJECTABLE OCTAPHARMA 2018-08-02 RX 351(a)
Primary humoral immunodefi-ciency, Chronic immune thrombocytopenic purpura
125644 ALBUMINEX SERUM ALBUMIN, HUMAN INJECTION INJECTABLE BIO PRODUCTS LABORATORY
2018-06-19 RX 351(a) Hypovolemia, ascites, hypoalbuminemia
125661 JIVI DAMOCTOCOG ALFA PEGOL INJECTION INJECTABLE BAYER 2018-08-29 RX 351(a) Hemophilia A
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (1/2)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
206709 DIACOMIT STIRIPENTOL ORAL CAPSULE BIOCODEX 2018-08-20 RX Type 1 Myoclonic Seizure
207078 LOKELMA SODIUM ZIRCONIUM
CYCLOSILICATE ORAL FOR SUSPENSION ASTRAZENECA 2018-05-18 RX Type 1 Hyperkalemia
207924 OLUMIANT BARICITINIB ORAL TABLET ELI LILLY 2018-05-31 RX Type 1 Rheumatoid Arthritis,
208078 FIRDAPSE AMIFAMPRIDINE
PHOSPHATE ORAL TABLET CATALYST 2018-11-28 RX Type 1
Lambert Eaton Myasthenic Syndrome
208623 GALAFOLD MIGALASTAT
HYDROCHLORIDE ORAL CAPSULE AMICUS 2018-08-10 RX Type 1 Fabry Disease
208627 TPOXX TECOVIRIMAT ORAL CAPSULE SIGA TECHNO. 2018-07-13 RX Type 1 Infections, Smallpox
208700 LUTATHERA LUTETIUM DOTATATE LU-177 INTRAVENOUS SOLUTION AAA USA 2018-01-26 RX Type 1 Cancer, Neuroendocrine
209229 LUCEMYRA LOFEXIDINE
HYDROCHLORIDE ORAL TABLET
US WORLDMEDS
2018-05-16 RX Type 1 Opioid Dependence
209299 TAVALISSE FOSTAMATINIB
DISODIUM ORAL TABLET RIGEL 2018-04-17 RX Type 1
Idiopathic Thrombocytopenic Purpura
209521 SEYSARA SARECYCLINE
HYDROCHLORIDE ORAL TABLET ALLERGAN 2018-10-01 RX Type 1 Acne
209627 ANNOVERA SEGESTERONE ACETATE;
ETHINYL ESTRADIOL VAGINAL RING
POPULATION COUNCIL
2018-08-10 RX Type 1 Contraception
209816 NUZYRA OMADACYCLINE TOSYLATE ORAL TABLET PARATEK 2018-10-02 RX Type 1 Infections, SSTI
209817 NUZYRA OMADACYCLINE TOSYLATE INTRAVENOUS POWDER PARATEK 2018-10-02 RX Type 1 Infections, SSTI
210166 MOTEGRITY PRUCALOPRIDE ORAL TABLET SHIRE 2018-12-14 RX Type 1 Constipation,
210238 DOPTELET AVATROMBOPAG MALEATE ORAL TABLET AKARX 2018-05-21 RX Type 1 Thrombocytopenia
210303 ZEMDRI PLAZOMICIN SULFATE INTRAVENOUS SOLUTION ACHAOGEN 2018-06-25 RX Type 1 Infections, Urinary Tract
210365 EPIDIOLEX CANNABIDIOL ORAL SOLUTION GW RESEARCH 2018-09-28 RX Type 1 Myoclonic Seizure
210450 ORILISSA ELAGOLIX SODIUM ORAL TABLET ABBVIE 2018-07-23 RX Type 1 Pain Management,
210493 AKYNZEO
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
INTRAVENOUS POWDER HELSINN 2018-04-19 RX Type 1 Nausea-Emesis
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (2/2)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
210598 YUPELRI REVEFENACIN INHALATION SOLUTION MYLAN 2018-11-09 RX Type 1 COPD
210656 DAURISMO GLASDEGIB ORAL TABLET PFIZER 2018-11-21 RX Type 1 Cancer, AML
210795 KRINTAFEL TAFENOQUINE SUCCINATE ORAL TABLET GSK 2018-07-20 RX Type 1 Infections, Malaria
210806 PIFELTRO DORAVIRINE ORAL TABLET MSD MERCK 2018-08-30 RX Type 1 Infections, HIV/AIDS
210854 XOFLUZA BALOXAVIR MARBOXIL ORAL TABLET GENENTECH 2018-10-24 RX Type 1 Infections, Influenza
210861 VITRAKVI LAROTRECTINIB ORAL CAPSULE LOXO ONCOLOGY
2018-11-26 RX Type 1 Cancer, Solid
210867 MOXIDECTIN MOXIDECTIN ORAL TABLET MDGH 2018-06-13 RX Type 1 Infections, Onchocerciasis
210868 LORBRENA LORLATINIB ORAL TABLET PFIZER 2018-11-02 RX Type 1 Cancer, NSCLC
210910 AEMCOLO RIFAMYCIN ORAL TABLET, DELAYED
RELEASE COSMO TECHNOLOGIES
2018-11-16 RX Type 1 Infections, ETEC
210922 ONPATTRO PATISIRAN SODIUM INTRAVENOUS SOLUTION ALNYLAM 2018-08-10 RX Type 1 Amyloidosis
210923 MULPLETA LUSUTROMBOPAG ORAL TABLET SHIONOGI 2018-07-31 RX Type 1 Thrombocytopenia
210951 ERLEADA APALUTAMIDE ORAL TABLET JANSSEN BIOTECH
2018-02-14 RX Type 1 Cancer, CRPC
211109 XERAVA ERAVACYCLINE
DIHYDROCHLORIDE INTRAVENOUS POWDER TETRAPHASE 2018-08-27 RX Type 1
Infections, Complicated Intra-Abdominal
211155 COPIKTRA DUVELISIB ORAL CAPSULE VERASTEM 2018-09-24 RX Type 1 Cancer, CLL
211172 TEGSEDI INOTERSEN SODIUM SUBCUTANEOUS SOLUTION AKCEA 2018-10-05 RX Type 1 Familial Amyloid Polyneuropathy
211192 TIBSOVO IVOSIDENIB ORAL TABLET AGIOS 2018-07-20 RX Type 1 Cancer, AML
211349 XOSPATA GILTERITINIB ORAL TABLET ASTELLAS 2018-11-28 RX Type 1 Cancer, AML
211651 TALZENNA TALAZOPARIB TOSYLATE ORAL CAPSULE PFIZER 2018-10-16 RX Type 1 Cancer, Breast Metastatic
211710 VITRAKVI LAROTRECTINIB ORAL SOLUTION LOXO ONCOLOGY
2018-11-26 RX Type 1 Cancer, Solid
210491 SYMDEKO
(COPACKAGED) IVACAFTOR; IVACAFTOR,
TEZACAFTOR ORAL TABLET, TABLET VERTEX 2018-02-12 RX Type 1 Cystic Fibrosis
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity / New Combination)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
210251 BIKTARVY BICTEGRAVIR SODIUM;
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ORAL TABLET GILEAD SCIENCES
2018-02-07 RX Type 1, 4 Infections, HIV/AIDS,
210496 BRAFTOVI ENCORAFENIB ORAL CAPSULE ARRAY BIOPHARMA
2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic
210498 MEKTOVI BINIMETINIB ORAL TABLET ARRAY BIOPHARMA
2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic
211288 VIZIMPRO DACOMITINIB ORAL TABLET PFIZER 2018-09-27 RX Type 1, 4 Cancer, NSCLC Metastatic
210589 OMEGAVEN FISH OIL TRIGLYCERIDES INTRAVENOUS EMULSION FRESENIUS KABI 2018-07-27 RX Type 1, 4 Cholestasis
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Active Ingredient)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
209381 PLENVU
ASCORBIC ACID; POLYETHYLENE GLYCOL
3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
ORAL FOR SOLUTION SALIX 2018-05-04 RX Type 2 Bowel Cleansing
211226 KHAPZORY LEVOLEUCOVORIN INTRAVENOUS POWDER SPECTRUM 2018-10-19 RX Type 2 Cancer, Chemo Side Effects
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3 (New Dosage Form) (1/2)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
207223 DIACOMIT STIRIPENTOL ORAL FOR SUSPENSION BIOCODEX 2018-08-20 RX Type 3 Myoclonic Seizure
206185 XELPROS LATANOPROST OPHTHALMIC EMULSION SUN PHARMA 2018-09-12 RX Type 3 Ocular Hypertension
207356 ARIKAYCE KIT AMIKACIN SULFATE INHALATION SUSPENSION, LIPOSOMAL
INSMED 2018-09-28 RX Type 3 Infections, Respiratory Tract
208255 SYMFI LO EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL
FUMARATE ORAL TABLET MYLAN 2018-02-05 RX Type 3 Infections, HIV/AIDS
208313 INFUGEM GEMCITABINE
HYDROCHLORIDE INTRAVENOUS SOLUTION SUN PHARM 2018-07-16 RX Type 3 Cancer, Pancreatic Metastatic
208742 DEXTENZA DEXAMETHASONE OPHTHALMIC INSERT OCULAR THERAPEUTIX
2018-11-30 RX Type 3 Ophthalmic Pain
209080 TIGLUTIK KIT RILUZOLE ORAL SUSPENSION ITALFARMACO 2018-09-05 RX Type 3 ALS
209128 DSUVIA SUFENTANIL CITRATE SUBLINGUAL TABLET ACELRX 2018-11-02 RX Type 3 Acute Pain
209184 INBRIJA LEVODOPA INHALATION POWDER ACORDA 2018-12-21 RX Type 3 Parkinson's
209311 JORNAY PM METHYLPHENIDATE
HYDROCHLORIDE ORAL
CAPSULE, EXTENDED
RELEASE IRONSHORE 2018-08-08 RX Type 3 ADHD
209353 ALTRENO TRETINOIN TOPICAL LOTION DOW 2018-08-23 RX Type 3 Acne
209355 JEMDEL HALOBETASOL PROPIONATE UNKNOWN DOW 2018-11-06 RX Type 3 Psoriasis,
209410 OSMOLEX ER AMANTADINE
HYDROCHLORIDE ORAL
TABLET, EXTENDED RELEASE
OSMOTICA 2018-02-16 RX Type 3 Parkinson's
209863 XYOSTED
AUTOINJECTOR TESTOSTERONE ENANTHATE SUBCUTANEOUS SOLUTION ANTARES 2018-09-28 RX Type 3 Hypoandrogenism
210115 PROGRAF TACROLIMUS ORAL FOR SUSPENSION ASTELLAS 2018-05-24 RX Type 3 Transplant Rejection
210361 QBREXZA GLYCOPYRRONIUM TOSYL-
ATE TOPICAL CLOTH DERMIRA 2018-06-28 RX Type 3 Hyperhidrosis
210428 KAPSPARGO
SPRINKLE METOPROLOL SUCCINATE ORAL
CAPSULE, EXTENDED RELEASE
SPIL 2018-01-26 RX Type 3 Hypertension,
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3 (New Dosage Form) (2/2)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
210563 IMBRUVICA IBRUTINIB ORAL TABLET PHARMACY-CLICS
2018-02-16 RX Type 3 Cancer, MCL
210655 PERSERIS KIT RISPERIDONE SUBCUTANEOUS FOR SUSPENSION,
EXTENDED RELEASE
INDIVIOR 2018-07-27 RX Type 3 Schizophrenia
210793 NUPLAZID PIMAVANSERIN TARTRATE ORAL CAPSULE ACADIA 2018-06-28 RX Type 3 Psychotic Disorders
210833 SYMPAZAN CLOBAZAM ORAL FILM AQUESTIVE THERAPEUTICS
2018-11-01 RX Type 3 Lennox-Gastaut Syndrome
211210 QMIIZ ODT MELOXICAM ORAL TABLET, ORALLY DISINTEGRATING
TERSERA 2018-10-19 RX Type 3 Osteoarthritis
211358 ORKAMBI IVACAFTOR; LUMACAFTOR ORAL GRANULE VERTEX 2018-08-07 RX Type 3 Cystic Fibrosis
208276 REMODULIN TREPROSTINIL INTRAVENOUS,
SUBCUTANEOUS SOLUTION
UNITED THERAPEUTICS
2018-07-30 RX Type 3 Pulmonary Arterial Hypertension
208612 BALCOLTRA ETHINYL ESTRADIOL; LEVONORGESTREL
ORAL TABLET AVION 2018-01-09 RX Type 3 Female Contraception
204441 JYNARQUE TOLVAPTAN ORAL TABLET OTSUKA 2018-04-23 RX Type 3 Polycystic Kidney Disease
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3,4 (New Dosage Form, New Combination)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
206976 LICART DICLOFENAC EPOLAMINE TOPICAL SHAMPOO INSTITUT BIOCHIMIQUE
2018-12-19 RX Type 3,4 Acute Pain
208085 XTRELUS GUAIFENESIN; HYDROCO-DONE BITARTRATE
ORAL TABLET ECI 2018-04-25 RX Type 3,4 Cough And Cold
210566 HALOBETASOL PROPIONATE
HALOBETASOL PROPIONATE TOPICAL AEROSOL, FOAM MAYNE 2018-05-24 RX Type 3,4 Psoriasis
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 4 (New Combination)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
22141 CIMDUO LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET MYLAN 2018-02-28 RX Type 4 Infections, HIV/AIDS
22142 SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET MYLAN 2018-03-22 RX Type 4 Infections, HIV/AIDS
22343
EFAVIRENZ, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET AUROBINDO 2018-08-15 RX Type 4 Infections, HIV/AIDS
205626 LAMIVUDINE, NEVIRAPINE, ZIDOVUDINE
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
ORAL TABLET MICRO LABS 2018-08-13 RX Type 4 Infections, HIV/AIDS
208653 APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
ORAL TABLET KEMPHARM 2018-02-23 RX Type 4 Acute Pain
210045 CONSENSI AMLODIPINE BESYLATE; CELECOXIB
ORAL TABLET KITOV 2018-05-31 RX Type 4 Pain Management
210132 BIJUVA ESTRADIOL; PROGESTERONE ORAL CAPSULE THERAPEUTICS- MD
2018-10-28 RX Type 4 Menopause
210455 SYMTUZA
COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ORAL TABLET JANSSEN 2018-07-17 RX Type 4 Infections, HIV/AIDS
210807 DELSTRIGO DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET MSD MERCK 2018-08-30 RX Type 4 Infections, HIV/AIDS
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 5 (New Formulation or Manufacturer) (1/3)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
209566 SEIZALAM MIDAZOLAM
HYDROCHLORIDE INTRAMUSCULAR SOLUTION MERIDIAN 2018-09-14 RX Type 5 Status Epilepticus
22517 NOCDURNA DESMOPRESSIN ACETATE SUBLINGUAL TABLET FERRING 2018-06-21 RX Type 5 Nocturia
202158 RADIOGENIX
SYSTEM
TECHNETIUM TC-99M SODIUM PERTECHNETATE
GENERATOR
INTRAVENOUS, INTRAVESICULAR,
OPHTHALMIC SOLUTION
NORTHSTAR MEDICAL
2018-02-08 RX Type 5 Diagnostic Agents
204417 ELEPSIA XR LEVETIRACETAM ORAL TABLET, EXTENDED
RELEASE SUN PHARMA 2018-12-20 RX Type 5 Epilepsy
205054 LUTRATE DEPOT
KIT LEUPROLIDE ACETATE INTRAMUSCULAR FOR SUSPENSION GP-PHARM 2018-08-28 RX Type 5 Cancer, Prostate
205580 BELRAPZO BENDAMUSTINE HYDRO-
CHLORIDE IV (INFUSION) SOLUTION EAGLE 2018-05-15 RX Type 5 Cancer, NHL
207962 ZTLIDO LIDOCAINE TOPICAL PATCH SCILEX 2018-02-28 RX Type 5 Neuropathic Pain
207987 ABLYSINOL ALCOHOL INTRA-ARTERIAL SOLUTION BELCHER 2018-06-21 RX Type 5 Cardiomyopathy
208042 CASSIPA BUPRENORPHINE HYDROCHLORIDE;
NALOXONE HYDROCHLORIDE SUBLINGUAL FILM TEVA 2018-09-07 RX Type 5 Opioid Dependence
208288 SOLUPREP CHLORHEXIDINE
GLUCONATE; ISOPROPYL ALCOHOL
TOPICAL SOLUTION 3M HEALTH CARE
2018-08-08 RX Type 5 Infections, Bacterial
208564 IMVEXXY ESTRADIOL VAGINAL INSERT THERAPEU-TICSMD
2018-05-29 RX Type 5 Vaginal Atrophy
208614 DOXERCALCI-
FEROL DOXERCALCIFEROL INJECTION INJECTABLE HOSPIRA 2018-07-24 RX Type 5 Secondary Hyperparathyroidism
208647 EZALLOR ROSUVASTATIN ORAL CAPSULE SUN PHARMAL 2018-12-18 RX Type 5 Hypertriglyceridemia
208901 TOLSURA ITRACONAZOLE ORAL CAPSULE MAYNE 2018-12-11 RX Type 5 Skin Infections, Fungal
208910 FIRVANQ KIT VANCOMYCIN
HYDROCHLORIDE ORAL FOR SOLUTION RXMTM 2018-01-26 RX Type 5 Diarrhea
208912 DEXYCU KIT DEXAMETHASONE INTRAOCULAR SUSPENSION EYEPOINT 2018-02-09 RX Type 5 Eye Inflammation,
209191 BORTEZOMIB BORTEZOMIB INTRAVENOUS,
SUBCUTANEOUS POWDER HOSPIRA 2018-07-12 RX Type 5 Cancer, Multiple Myeloma
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 5 (New Formulation or Manufacturer) (2/3)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
209260 ATROPINE SULFATE
ATROPINE SULFATE
IV (INFUSION), INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
SOLUTION FRESENIUS KABI 2018-01-26 RX Type 5 Intoxication/Poisoning
209481 VANCOMYCIN HYDROCHLO-
RIDE
VANCOMYCIN HYDROCHLORIDE
INTRAVENOUS POWDER MYLAN 2018-07-10 RX Type 5 Sepsis
209607 AZEDRA IOBENGUANE I 131 INJECTION INJECTABLE PROGENICS 2018-07-30 RX Type 5 Pheochromocytoma
209830 ARISTADA INI-
TIO KIT ARIPIPRAZOLE LAUROXIL INTRAMUSCULAR
SUSPENSION, EXTENDED
RELEASE ALKERMES 2018-06-29 RX Type 5 Schizophrenia
209844 LYMEPAK DOXYCYCLINE HYCLATE ORAL TABLET CHARTWELL 2018-06-15 RX Type 5 Infections, Lyme Disease
210308 YONSA ABIRATERONE ACETATE ORAL TABLET SUN PHARMA 2018-05-22 RX Type 5 Cancer, CRPC Metastatic
210331 YUTIQ FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT EYEPOINT 2018-10-12 RX Type 5 Uveitis
210565 INVELTYS LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION/
DROPS KALA 2018-08-22 RX Type 5 Eye Inflammation
210607 ARAKODA TAFENOQUINE SUCCINATE ORAL TABLET 60 DEGREES 2018-08-08 RX Type 5 Infections, Malaria
210913 CEQUA CYCLOSPORINE OPHTHALMIC SOLUTION SUN PHARMA 2018-08-14 RX Type 5 Dry Eye Syndrome
210997 GLYRX-PF GLYCOPYRROLATE INTRAMUSCULAR,
INTRAVENOUS SOLUTION EXELA PHARMA 2018-07-11 RX Type 5 Anesthesia
211158 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER AMNEAL 2018-08-02 RX Type 5 Infections, SSTI
211284 TEMIXYS LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET CELLTRION 2018-11-16 RX Type 5 Infections, HIV/AIDS
211580 SPY AGENT GREEN KIT
INDOCYANINE GREEN INTRAVENOUS, INTERSTITIAL
POWDER NOVADAQ 2018-11-21 RX Type 5 Diagnostic Agents
212319 ATROPINE
AUTOINJECTOR ATROPINE INTRAMUSCULAR SOLUTION RAFA LABS 2018-07-09 RX Type 5 Intoxication/Poisoning
22344
LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET AUROBINDO 2018-05-15 RX Type 5 Infections, HIV/AIDS
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 5 (New Formulation or Manufacturer) (3/3)
Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing Application Indication
208744 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER ACCORD 2018-01-18 RX Type 5 Infections, SSTI
209552 ARGATROBAN
IN SODIUM CHLORIDE
ARGATROBAN INTRAVENOUS SOLUTION AUROBINDO 2018-11-27 RX Type 5 Anticoagulant, antithrombotic
210906
CALCIUM GLUCONATE IN
SODIUM CHLORIDE
CALCIUM GLUCONATE INTRAVENOUS SOLUTION HQ SPECIALITY 2018-10-29 RX Type 5 Hypocalcemia
207964 READYPREP
CHG CHLORHEXIDINE
GLUCONATE TOPICAL CLOTH MEDLINE 2018-11-20 RX Type 5 Infections, Surgical Preparation
205920 PRIMATENE
MIST EPINEPHRINE INHALATION AEROSOL ARMSTRONG 2018-11-07 OTC Type 5,8 Asthma
FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 9 (New Indication …)
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
208855 VERZENIO ABEMACICLIB ORAL TABLET ELI LILLY 2018-02-26 RX Type 9 Cancer, Breast Metastatic
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Tentative Approvals
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
210296 MONOMETHYL
FUMARATE MONOMETHYL FUMARATE ORAL CAPSULE BANNER 2018-11-16 TENTAPP Type 2 MS, Relapsing Remitting
210661 PEMETREXED PEMETREXED INJECTION INJECTABLE APOTEX 2018-03-28 TENTAPP Type 2 Cancer, NSCLC Metastatic
210136 BRIXADI BUPRENORPHINE SUBCUTANEOUS INJECTION, EXTENDED RELEASE
BRAEBURN 2018-12-21 TENTAPP Type 3, 4 Opioid Dependence
205493
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
ORAL TABLET MICRO LABS 2018-01-25 TENTAPP Type 4 Infections, HIV/AIDS, Other
210237 DOLUTEGRAVIR EMTRICITABINE;
TENOFOVIR
DOLUTEGRAVIR; EMTRICITABINE;
TENOFOVIR ALAFENAMIDE ORAL TABLET MYLAN 2018-02-09 TENTAPP Type 4 Infections, HIV/AIDS, Other
209764 LUSDUNA INSULIN GLARGINE INJECTION INJECTABLE MERCK SHARP DOHME
2018-02-22 TENTAPP Type 5 Diabetes, Type 2
210540 LOPINAVIR; RITONAVIR
LOPINAVIR; RITONAVIR ORAL UNKNOWN MYLAN 2018-08-16 TENTAPP Type 5 Infections, HIV/AIDS, Other
205389 EFAVIRENZ EFAVIRENZ ORAL TABLET MICRO LABS 2018-02-23 TENTAPP Type 5 Infections, HIV/AIDS, Other
207970 CABAZITAXEL
INJECTION CABAZITAXEL INJECTION INJECTABLE ACTAVIS 2018-01-17 TENTAPP Type 5 Cancer, CRPC Metastatic
210326 FULVESTRANT FULVESTRANT INJECTION INJECTABLE FRESENIUS KABI 2018-06-29 TENTAPP Type 5 Cancer, Breast, Other
210850 SINCALIDE SINCALIDE INJECTION INJECTABLE MAIA 2018-02-23 TENTAPP Type 5 Diagnostic Agents, Other
210601 BENDA-
MUSTINE HY-DROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE
IV (INFUSION) SOLUTION APOTEX 2018-11-13 TENTAPP Type 5 Cancer, CLL
All Rights Reserved - PharmaCircle LLC (2019)
FDA Drugs Division - 2018 NDA (New Drug) Approvals - Notable Supplements
Application Number
Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing
Status Application
Category Indication
21945 MAKENA 17 ALPHA-
HYDROXYPROGESTERONE CAPROATE
INJECTION AUTOINJECTORS,
DISPOSABLE AMAG 2018-02-14 RX Supplement Preterm Birth
206538 TOUJEO MAX
SOLOSTAR INSULIN GLARGINE
RECOMBINANT INJECTION
INJECTION PENS, DISPOSABLE
SANOFI 2018-03-26 RX Supplement Diabetes
125472 ACTEMRA TOCILIZUMAB INJECTION AUTOINJECTORS,
DISPOSABLE CHUGAI 2018-11-19 RX Supplement Rheumatoid Arthritis
207534 SYMJEPI EPINEPHRINE INJECTION SPECIALTY SYRINGES
ADAMIS 2018-09-27 RX Supplement Anaphylaxis
103976 XOLAIR OMALIZUMAB INJECTION PREFILLED SYRINGE
GENENTECH 2018-09-28 RX Supplement
Allergic Rhinitis Urticaria Asthma Sinusitis
19959 NOVOLIN N
(FlexPen) INSULIN ISOPHANE INJECTION
INJECTION PENS, DISPOSABLE
NOVO NORDISK 2018-06-01 OTC Supplement Diabetes
19991 NOVOLIN 70/30
(FlexPen) INSULIN,
HUMAN RECOMBINANT INJECTION
INJECTION PENS, DISPOSABLE
NOVO NORDISK 2018-06-01 OTC Supplement Diabetes
19938 NOVOLIN R (FlexPen)
INSULIN, HUMAN RECOMBINANT
INJECTION INJECTION PENS,
DISPOSABLE NOVO NORDISK 2018-06-01 OTC Supplement Diabetes
All Rights Reserved - PharmaCircle LLC (2019)