Teva Announces Approval Of Generic Fosamax(R) Tablets, 5 Mg, 10 Mg, 35 Mg, 40 Mg And 70 Mg

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 08 Feb 2008 - 1:00 PDT

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Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced 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.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd.