Impax Pharma: FDA Extends PDUFA Date For Review Of RYTARY NDA

(RTTNews) - Impax Pharmaceuticals, the branded products division of Impax Laboratories Inc. (IPXL), announced that the U.S. FDA has extended the PDUFA date for its review of the RYTARY (IPX066) New Drug Application from October 9, 2014, to January 9, 2015. RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease.

The company amended the chemical, manufacturing and control section of the RYTARY NDA subsequent to its submission of responses to the July 26, 2014 Form 483 observations at the Taiwan facility. The FDA notified the company that such amendment constituted a major amendment, and has extended the PDUFA date to review the additional information.