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

Quick Facts

Editors Pick
Anglo-Dutch oil giant Royal Dutch Shell plans to cut 2,200 more jobs, as the company continues to face lower oil prices, media reported Wednesday citing an emailed statement. The latest round of cuts would bring the total job cuts this year to at least 5,000 globally. In the U.K. and Ireland, the company plans to reduce staff working in exploration and production by 475. Tiffany & Co. (TIF) reported first-quarter net earnings of $87 million, or $0.69 per share compared to $105 million, or $0.81 per share, in the prior year. The company noted that its first-quarter results included a tax benefit of $0.05 per share related to the settlement of a tax examination. On average,... Shares of Marks & Spencer Group plc were losing around 8 percent in the early morning trading in London, after the retailer reported lower profit in its fiscal 2016, hurt mainly by weak results at clothing & Home segment and lower UK LFL sales. Looking ahead, the company warned about profit, and said it sees a similar sales trend in fiscal 2017.
comments powered by Disqus
Follow RTT