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October ANDAs/AADAs

Executive Summary

FDA Office of Generic Drugs (OGD) approves 14 ANDAs and four AADAs during the month and gives tentative approval to one ANDA. A Nov. 1 OGD memo notes that because some applications include more than one strength, OGD approved the equivalent of 33 new and four tentative applications. The 37 equivalent approvals is the highest since the 60-plus approvals in April 1989. Previously, the highest number of OGD monthly approvals since the generic drug scandal was 29 in June 1993. Exclusivity for Bristol-Myers Squibb's Corgard (nadolol) expired in January 1993. The Nov. 8 issue of "The Pink Sheet" (p. 1) incorrectly reported the patent expiration date in relation to Mylan receiving the first nadolol ANDA approval.
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PS023608

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