Jun 12, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' hypertension treatment Diovan(R) (Valsartan) Tablets, 40 mg, 80 mg, 160 mg and 320 mg. 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.
The brand product had U.S. sales of approximately $1.5 billion for the twelve months ended March 30, 2008, according to IMS data.
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