UPDATE 1-Teva wins tentative U.S. OK for generic Diovan
(New throughout; adds NEW YORK dateline)
NEW YORK, June 12 (Reuters) - U.S. regulators have granted tentative approval to Teva Pharmaceutical Industries Ltd's TEVA.O generic form of Novartis AG's (NOVN.VX) blockbuster high blood pressure drug Diovan, Teva said on Thursday.
Israel-based Teva said the U.S. Food and Drug Administration had given it tentative approval to sell generic tablet forms of the medicine, in dosages of 40 milligrams, 80 mg, 160 mg and 320 mg.
Final approval is not expected until Novartis patents on Diovan expire in September 2012, or later if the branded product obtains an additional period of marketing exclusivity, Teva said.
Diovan had U.S. sales of $1.5 billion for the 12 months ended March 30, 2008, Teva said. (Reporting by Ransdell Pierson; editing by John Wallace)
- Up to 18 exposed to U.S. Ebola patient, including children |
- Israel's Netanyahu to Obama: Don't allow Iran deal that leaves it at nuclear threshold
- First Ebola case diagnosed in the United States: CDC |
- Turkey vows to fight Islamic State, coalition strikes near border |
- Hong Kong leader plays waiting game, protesters demand he resigns |