Teva Pharmaceutical Industries 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 GlaxoSmithKline's Imitrex(R) Tablets, 25 mg, 50 mg and 100 mg for treatment of acute migraine attacks

JERUSALEM, Israel | February 10, 2009 | Teva Pharmaceutical Industries Ltd. (TEVA: TEVA 42.13, -0.28, -0.7%) 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 GlaxoSmithKline's Imitrex(R) Tablets, 25 mg, 50 mg and 100 mg for treatment of acute migraine attacks. Shipment of this product has commenced.

As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

Annual sales of this product were approximately $1 billion in the United States for the twelve months that ended December 30, 2008, 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 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. Over 80 percent of Teva's sales are in North America and Europe.

SOURCE: Teva Pharmaceutical Industries Ltd. 

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