Feb 6, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's osteoporosis treatment Fosamax(R) (Alendronate Sodium) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. Shipment of the product will begin immediately.
As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
The brand product had annual sales of approximately $1.9 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
No comments:
Post a Comment