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022288s000_PharmR

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   CENTER FOR DRUG EVALUATION AND RESEARCH  APPLICATION NUMBER:   22-006   PHARMACOLOGY REVIEW(S)  Comments on N22288 bepotastine besilate Bepreve From A. Jacobs 8/27/09 I concur that there are no outstanding pharm/tox issues and the pregnancy category should be C, since the adverse effects might be applicable to the use of the API for other indications for which systemic exposure might be considerably higher. My previous comments to the reviewer on the pharm/tox portion of labeling and on the  pharm/tox review have been addressed.  Linked Applications SubmissionType/Number Sponsor Name Drug Name / Subject-------------------- -------------------- -------------------- ------------------------------------------NDA 22288 ORIG 1 ISTAPHARMACEUTICALSBEPOTASTINE BESILATEOPHTHALMIC SOLUTION ---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------  /s/ ----------------------------------------------------ABIGAIL ABBY C C JACOBS08/27/2009    DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PHARMACOLOGY/TOXICOLOGY REVIEW AND EVALUATION    NDA NUMBER: 22-288  SERIAL NUMBER: 0000, 0008, 0014, 0016 and 0017  DATE RECEIVED BY CENTER: 11/14/08  PRODUCT: Bepreve TM  INTENDED CLINICAL POPULATION: allergic conjunctivitis in patients aged 3 years and older SPONSOR: ISTA, Pharmaceuticals®, Inc., Irvine, CA  DOCUMENTS REVIEWED: Module 4 Documents submitted 11/14/2008 and 3/11/2009, 5/29/2009, 6/5/2009 and 6/12/2009 REVIEW DIVISION: Division of Anti-Infective and Ophthalmology Products (HFD-520) PHARM/TOX REVIEWER: Theresa Allio, Ph.D.  PHARM/TOX SUPERVISOR: Wendelyn Schmidt, Ph.D.  DIVISION DIRECTOR: Wiley Chambers, M.D. PROJECT MANAGER: Rafael Rodriguez Date of review submission to Division File System (DFS): July 21, 2009
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