Impax Pharmaceuticals announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY™ (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015.

The Company amended the chemical, manufacturing and control (CMC) 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. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has extended the PDUFA date to review the information. No additional information was requested by the Agency.

RYTARY (IPX066) is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of Parkinson's disease. It is not approved or licensed anywhere in the world. Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) were positive and have previously been announced and approved by the FDA. However, they never received final FDA approval due to ongoing problems at their manufacturing facility. After an extensive delay, and supposed improvements, the FDA was going to conduct another inspection prior to Oct 9. However, this has now been delayed again for another three months.


http://www.marketwatch.com/story/imp...015-2014-09-17