The brand version of the osteoporosis treatment has US annual sales of $1.9 billion.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that the FDA (US Food and Drug Administration) has granted final approval for the company’s ANDA (abbreviated new drug application) to market its generic version of Merck’s osteoporosis treatment Fosamax (alendronate sodium) tablets in 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg. doses. Teva said that shipment of the product would 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.
According to Teva, the brand product had annual sales of approximately $1.9 billion in the US for the twelve months ended September 30, 2007. The figure is based on IMS sales data.
Teva shares closed 1.38% higher on the Tel Aviv Stock Exchange today, at NIS 168.80. The company is due to release its quarterly financials on February 12.
Published by Globes [online], Israel business news - www.globes.co.il - on February 6, 2008
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