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GENERIC DRUG APPROVALS INCREASE BY 41 TO 229 IN 1992; 31 ARE FIRST-TIMERS

Executive Summary

The Office of Generic Drugs' approvals of a total of 229 ANDAs and AADAs during 1992 is 41 more than were cleared by the agency in 1991 ("The Pink Sheet" Jan. 20, 1992, In Brief). OGD approved 31 drugs that were the first generic approvals of innovator products. In 1991, FDA okayed 12 first-time generic approvals. Many of the 31 first generic approvals are for equivalents of important innovator products, such as Marion Merrell Dow's Cardizem (diltiazem), Pfizer's Feldene (piroxicam), Syntex' Naprosyn (naproxen), Wyeth-Ayerst's Orudis (ketoprofen), Searle's Calan-SR/Knoll's Isoptin-SR (verapamil extended-release tabs), Tavist (clemastine fumarate), Sandoz' Pamelor (nortriptyline HCl), McNeil's Imodium-AD (loperamide), Ortho's Monistat (miconazole) and Procter & Gamble Pharmaceuticals' Macrodantin (nitrofurantoin macrocrystals). On Dec. 31, Schein's Danbury Pharmacal subsidiary gained approval for the first generic version of nitrofurantoin macrocrystals ("The Pink Sheet" Jan. 4, T&G-7). Schein said it expects to begin shipping its version of the P&G treatment for urinary tract infections in February, pending the completion of a post-approval validation inspection by FDA. Product launch will be accompanied by a four-page flier sent to 43,000 pharmacists, wholesalers and drug chain headquarters and pharmacy journal ads and a free goods program, the company said. OGD also cleared a total of 3,483 generic drug supplements in 1992, which represents 110 fewer than in 1991 when the office approved 3,593 supplements. OGD said that its backlog of overdue applications continues to go down. In fact, because OGD's workload has become more manageable, the office has been able to detail an OGD chemist to the Pilot Drug Evaluation Staff to review manufacturing supplements and to receive supplements from three ODE divisions for review ("The Pink Sheet" Oct. 5, 1992, p. 9).
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