Teva gains tentative approval for generic Diovan

22 June 2008

Israel-headquartered Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted tentative approval for its Abbreviated New Drug Application to market its generic version of Novartis' hypertension treatment Diovan (valsartan) tablets, 40mg, 80mg, 16mg and 320mg. Final approval of this product is expected upon expiry of patent protection for the brand product in September 2012, as well as any periods of marketing exclusivity that may be awarded.

Branded Diovan generated US sales of around $1.5 billion for the12 months ended March 30, 2008, according to IMS data quoted by Teva.

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