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FDA Office of Generic Drugs: Approvals and Tentative Approvals of Generic Drugs

May 1, 2005

FDA Office of Generic Drugs: Approvals and Tentative Approvals of Generic Drugs

Abbreviated New Drug Applications have been increasing in recent years, but the resources allocated to the Office of Generic Drugs for review of the applciations have not.

Year	1999	2000	2001	2002	2003	2004	2005
Approvals	198	232	241	296	284	320	359*
Tentative Approvals	68	62	69	68	89	93	86*
* Applications projected for FY 2005. Source: FDA Office of Generic Drugs, May 2005.