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Teva Announces Approval and Shipment of Generic Omnicef Capsules and POS

Antibiotic :: Teva Announces Approval and Shipment of Generic Omnicef Capsules and POS

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Applications (ANDA) to market its generic versions of Abbott's antibiotic Omnicef? (Cefdinir) Capsules, 300 mg, and for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL. Teva has commenced shipment of these products.

Omnicef? Capsules and Omnicef? for Oral Suspension had annual sales of approximately $325 million and $533 million, respectively, in the U.S. based on IMS sales data.

Teva is currently in patent litigation concerning this product in the United States District Court for the Northern District of Illinois. A suit was brought against Teva in March 2007 involving Abbott's U.S. Patent No. 4,935,507.

On May 3, 2007, the District Court denied Abbott's request for a preliminary injunction against Teva with respect to its cefdinir products. The Court found that Abbott had not proven a likelihood of success on their allegations of infringement of Teva's products.

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, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

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