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Teva Pharmaceutical Industries 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® (Valsartan) Tablets, 40 mg, 80 mg, 160 mg and 320 mg
Jerusalem, Israel | June 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® (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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd., |
