Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Teva Says FDA Decides Its Unit Is Sole First-to-file On Provigil - Quick Facts

Teva Pharmaceutical Industries Ltd. (TEVA: Quote) on Thursday said the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's ANDA alone is entitled to 180-day exclusivity.

Cephalon launched generic Provigil on March 29 and the FDA has also decided that such launch triggered the exclusivity.

Teva expects Par Pharmaceutical to launch a second generic product on April 6 pursuant to the agreement with the FTC in connection with the Cephalon acquisition.

Click here to receive FREE breaking news email alerts for Teva Pharmaceutical Industries Limited and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Colorado based doctor Dilip Joseph, who was kidnapped by the Taliban discusses his ordeal in detail in a book published by Amazon on Tuesday. Extending the rebound seen over the course of the previous session, stocks moved sharply higher during trading on Friday. The gains on the day partly offset the recent sell-off on Wall Street, although the major averages remain well off their mid-September highs. While the Ebola outbreak in the U.S. has thus far been limited to just three people, the results of a new CBS News poll suggest that news of the disease has contributed to a sharp drop in public confidence in the Centers for Disease Control and Prevention.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.