Sepracor's STEDESA NDA: FDA extends PDUFA action date

Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the STEDESA™ (eslicarbazepine acetate) New Drug Application (NDA) on April 30, 2010, which is a three-month extension to the original Prescription Drug User Fee Act (PDUFA) date of January 30, 2010.

In November 2009, at the request of the FDA, Sepracor submitted additional information about STEDESA to the agency. This additional information was received by the FDA less than 90 days prior to the PDUFA action date of January 30, 2010. The FDA has authority to extend the PDUFA action date when additional data is provided by the NDA sponsor less than 90 days prior to the original PDUFA action date. This additional time is typically needed by the FDA to ensure that the agency has adequate time to review the additional information received.