FDA gives Teva tentative approval for generic Diovan

6/23/2008

JERUSALEM The Food and Drug Administration has granted tentative approval for Teva Pharmaceutical Industries’ generic version of Novartis’ Diovan, Teva announced June 12.

Diovan, known generically as valsartan, is used to treat hypertension. The FDA’s tentative approval covers generic valsartan tablets in doses of 40mg, 80mg, 160mg and 320mg. Teva expects the FDA to grant final approval for the tablets when Novartis’ patent for the drug expires, in September 2012.

Diovan had sales of about $1.5 billion for the 12 months ending March 30, according to IMS data.

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