Teva Pharmaceutical Industries Ltd. announced that the US 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.
According to a Teva press release, the 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 US sales of approximately $1.5 billion for the twelve months ended March 30, 2008, according to IMS data.
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.