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Mylan vs. FDA (And Ranbaxy): Diovan Exclusivity Forfeiture Edition

 
• By Brenda Sandburg

In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.

Mylan Laboratories Ltd. is challenging FDA’s award of generic Diovan (valsartan) 180-day marketing exclusivity to Ranbaxy Laboratories Ltd., contending that Ranbaxy forfeited its exclusivity by failing to get timely tentative approval of its ANDA.

Mylan filed suit against the agency Oct. 2 requesting the court vacate FDA’s exclusivity award to Ranbaxy and...

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