Teva Pharmaceutical Industries Ltd said 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 Lilly's osteoporosis treatment Evista (Raloxifene Hydrochloride) Tablets, 60 mg.
The brand product had annual sales of approximately $691 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the US District Court for the Southern District of Indiana. A trial date has not been set.