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FDA 1999 stats

Executive Summary

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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Biologicals Approved In 1999

Product.......... Humate-P (S, V) Ingredient....... Antihemophilic factor/von Willebrand factor complex (human) Sponsor.......... Centeon Pharma GmbH Indication....... New indication for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Date Approved.... 4/1/1999 Application No... 96-1099 Footnote......... Standard review; Orphan drug

First Time Generics Approved In 1999

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