Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

4/5/2012 8:54 AM ET

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
Housing starts in the U.S. showed a notable increase in the month of March, according to a report released by the Commerce Department on Wednesday, although starts still came in well below economist estimates. The report showed that housing starts climbed 2.8 percent to an annual rate of 946,000 in March from the revised February estimate of 920,000. After moving mostly higher over the course of the two previous sessions, stocks may see some further upside in early trading on Wednesday. The major index futures are currently pointing to a higher open for the markets, with the Dow futures up by 63 points. The U.K. unemployment rate fell below the 7 percent threshold to a five-year low in February and average earnings finally moved above inflation reducing the squeeze on household finances. The jobless rate came in at 6.9 percent of the labor force, the lowest since February 2009, data from the Office for National Statistics showed Wednesday.
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.