logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Accepts Impax Pharma NDA Filing For IPX066 - Quick Facts

Impax Laboratories, Inc.'s (IPXL) branded products division, Impax Pharmaceuticals, said the U.S. Food and Drug Administration has accepted for filing the company's New Drug Application, or NDA, for IPX066 for the treatment of idiopathic Parkinson's disease submitted to the Agency on December 21, 2011. The Prescription Drug User Fee Date for a decision by the FDA is October 21, 2012.

IPX066 is a patented extended release capsule formulation of carbidopa-levodopa.

The NDA included data from three controlled Phase III studies and two open label extensions of IPX066 in both early and advanced Parkinson's disease.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions. Oil company Exxon Mobil Corp. on Friday reported a 63 percent fall in profit for the first quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results were impacted by the fall in crude oil prices and weaker refining margins. However, Exxon Mobil's earnings beat analysts' estimates, while Chevron's loss was wider than their expectations.
comments powered by Disqus
Follow RTT