FY 2011 Innovative Drug Approvals -35 new drugs

FY 2011 Innovative Drug Approvals -35 new drugs (To download detail report: (www.biopreneur.org)

In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.

Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months. Seven of the new medicines provide major advances in cancer treatment; ten are for rare or “orphan”; three were approved using “accelerated approval,” diseases; one for melanoma and one for lung cancer