BioCentury
ARTICLE | Politics & Policy

FDA highlights drug approvals in FY12

December 6, 2012 2:14 AM UTC

FDA approved 35 new drugs in the fiscal year ending Sept. 30, the same number of drugs that were approved in FY11, according to a report released by the agency on Wednesday. FDA noted that 77% of the approvals were completed in a single review cycle and that 34 of the approved drugs met their PDUFA date. Additionally, nine of the drugs were approved for Orphan diseases. FDA also said 24 of the approvals occurred in the U.S. before any other country. ...