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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207318Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 207318Orig1s000 - Food and Drug Administration · Sub-Score Reviewer's Assessment: Facility Name Profile Overall Initial Product Facility Risk Recommendation ... that the thug meets

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207318Orig1s000

CHEMISTRY REVIEW(S)

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug AdministrationRockville MD 20857

MEMORANDUM

Date: April 14, 2016

From: David Claffey‚ Ph.D., CMC Lead, OPQ/ONDP and ATL for NDA 207318

To: NDA 207318

Subject: OPQ Approval Recommendation for NDA 207318, NUPLAZID (pimavanserin)tablets

This memorandum is an addendum to the Office of Pharmaceutical Quality (OPQ) 19 FEB 2016 review for NDA 207318 where an approval recommendation was made on receipt of an acceptable recommendation from the OPF facilities reviewer. On 12 APR 2016 OPF facilities made an overall acceptable recommendation (Attached).

Therefore this application is recommended for approval from an OPQ perspective.

David J. Claffey -S

Digitally signed by David J. Claffey -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300225565, cn=David J. Claffey -S Date: 2016.04.14 13:08:58 -04'00'

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