Proton Pump Inhibitors - CME Conferences

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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 How Did the “Orange Book” Get it’s Nickname? • When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?" “Orange Book” FDA • All FDA approved drug products listed (NDA’s, OTC’s & ANDA’s) • Therapeutic equivalence codes –“A” = Substitutable –“B” = Inequivalent, NOT substitutable • Expiration dates: patent and exclusivity • Reference Listed Drugs/brand drugs identified by FDA for generic companies to compare their proposed products with Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA Ratings FDA • “A” rated drugs are considered bioequivalent to the brand name original. – They either have been demonstrated to be so by human bioavailability study (“AB”) or considered inherently unlikely to have bioavailability problems (“AA”) – Other “A” designations (AN, AO, AP, AT) refer to nonoral formulations considered bioequivalent by the FDA – Only “A” rated products are interchangeable with their brand name equivalents by the FDA Center for Drug Evaluation and Research Levothyroxine Ratings FDA • UNITHROID (STEVENS J) – 0.025MG AB1 • LEVOTHYROXINE SODIUM (MYLAN) – 0.025MG AB1 • LEVOXYL (KING PHARMS) – 0.025MG AB1 • SYNTHROID (ABBOTT) – 0.025MG AB1 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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