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Generic Depo-Provera Granted Final Approval by FDA

JERUSALEM--(BUSINESS WIRE)--Oct. 27, 2004--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the U.S. Food and Drug Administration has granted final approval for Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL pre-filled syringe. A launch date has not yet been finalized.

Medroxyprogesterone Acetate Injectable Suspension is the generic equivalent of Pfizer's Depo-Provera®, an injectable contraceptive.

Annual sales of the brand product sold in syringes are approximately $109 million.

This is the second presentation of this product for which Teva has obtained a generic drug approval. In July, the FDA granted final approval for Teva's ANDA for Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL in single-dose vials. Shipment of this product commenced in September.

Source: Teva Pharmaceutical Industries

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