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.