FY 2012 Innovative Drug Approvals Report Released

The FDA approved 35 new drugs in the fiscal year ending Sept. 30 (FY2012), the same number of drugs that were approved in FY2011, according to a recent report. About 77% of the approvals were completed in a single review cycle, whileat 34 of the approved drugs met their Perscription Drug User Fee Act PDUFA date.  Of note, 9 drugs were approved for Orphan diseases (generally defined as a disease that strikes a small population). Twenty-four of the approvals occurred in the U.S. before any other country.

A listing of their approved drugs and their indications is also included in the report.

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