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First Time Generics Approved In 1999

Executive Summary

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FDA 1999 stats

CDER received 140 NDAs during 1999. CBER reports 39 new product license applications were submitted in 1999, ten more than in 1998. CBER's approvals for 1999 included four new therapeutic BLA approvals, one NDA for a biologic and one BLA for a significant new indication. (1"The Pink Sheet" Jan. 17, p. 16) omitted BioTime's Hextend for hypovolemia during surgery and counted a different number of new therapeutic BLA approvals. The average time for approval of the five new biologics was 17.1 months. The number of first time generics approved in 1999 was 43 (2"The Pink Sheet" Jan 17, p. 14)

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