Proton Pump Inhibitors - CME Conferences

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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA Requirements for Generic Ophthalmics • The following companies that offer generic latanoprost in the same formula as Xalatan include: – Brand Xalatan by Pfizer - $81.85 AWC/2.5ml 0.005% soln – Bausch + Lomb - $13.43 AWC/2.5ml 0.005% soln – Falcon Pharmaceuticals Ltd., an affiliate of Alcon Laboratories, Inc. (owned by Novartis) - $10.00 AWC/2.5ml 0.005% soln – Apotex Corp. - $53.12 AWC/2.5ml 0.005% soln – Greenstone LLC (owned by Pfizer) - $13.38 AWC/2.5ml 0.005% soln – Mylan – $6.90 AWC/2.5ml 0.005% soln – Note that all of the above have FDA Therapeutic Equivalent Codes of AT and are considered by the FDA therapeutically equivalent FDA Orange Book for Solutions • All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post- 1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data. 41 Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA When can a Generic Drug be Marketed? •After patent & exclusivity protection ends, or •patent owner waives its rights, or •patent challenge is won, and •FDA requirements are met Center for Drug Evaluation and Research FDA APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 31st EDITION THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF MANAGEMENT DIVISION OF DATABASE MANAGEMENT 2011 Electronic Orange Book - http://www.fda.gov/cder/ob/ Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
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Proton Pump Inhibitors - CME Conferences

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