Log in
Login
Password
Remember
Lost password
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 

4-Traders Homepage  >  Shares  >  Nasdaq  >  Mylan Inc       US6285301072

SummaryChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector news 

Mylan Seeks To Overturn FDA's Provigil Decision

04/05/2012 | 01:10pm US/Eastern

Mylan Inc. (>> Mylan Inc.) said it is seeking to overturn a decision by the U.S. Food and Drug Administration that awarded Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) exclusivity for its generic version of Cephalon Inc.'s wakefulness drug Provigil.

The generic drug maker said Thursday it has filed a lawsuit against the FDA in the U.S. district court for the District of Columbia. Mylan is seeking an immediate court order entitling it to exclusivity as well as immediate approval for its abbreviated new drug application.

Mylan alleges Teva did not maintain valid certifications as a result of its acquisition last year of Cephalon and thus is not entitled to exclusivity based on patent certifications. Mylan also alleges that the FDA should have found Mylan as the sole first filer on one of the patents for Provigil.

Earlier Thursday, Teva said the FDA has decided that Teva is the sole first-to-file for both of Provigil's patents, which entitled the company to 180-day exclusivity. The FDA decided that Cephalon's launch of generic Provigil on March 29 triggered the exclusivity.

In October, the Federal Trade Commission required Teva to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant in connection with Teva's acquisition of Cephalon. The FTC agreement also required Teva to enter a supply agreement that allows a competing firm, Par Pharmaceuticals Inc. (PRX), to sell a generic version of Provigil in 2012.

Teva expects Par Pharmaceuticals to launch a second generic product on April 6.

Mylan shares slipped 1.8% to $22.74 in recent trading. The stock is up 5.9% so far this year.

 
   -By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com 

Stocks mentioned in the article : Mylan Inc.
React to this article
Latest news on MYLAN INC
06/29 Second-quarter M&A close to record amid mega deals
06/22 EXCLUSIVE : CVC and Temasek to buy $2 billion generic drugs firm Alvogen
06/22 CVC and Temasek to buy $2 billion generic drugs firm Alvogen
06/19DJTeva Takes 4.6% Stake in Mylan
06/19DJTeva Takes 4.6% Stake in Mylan
06/18DJTeva's Copaxone Patent Again Struck Down by U.S. Court -- 2nd Update
06/18DJTeva's Copaxone Patent Again Struck Down by U.S. Court -- Update
06/18DJTeva's Copaxone Patent Loses Again
06/18DJU.S. Court Again Strikes Down Teva's Copaxone Patent
06/18 MYLAN NV : U.S. Court of Appeals for the Federal Circuit Finds Teva's '808 Copax..
Advertisement
Chart
Duration : Period :
Mylan Inc Technical Analysis Chart | US6285301072 | 4-Traders
Income Statement Evolution
More Financials