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FDA Approves Generic Brethine Injection

JERUSALEM--(BUSINESS WIRE)--July 21, 2004--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Terbutaline Sulfate Injection, 1 mg/mL. Shipment of this product is expected to begin immediately.

Teva's Terbutaline Sulfate Injection is a generic equivalent of Brethine(R) Injection, which is marketed by AAI Pharmaceuticals. This product is a bronchodilator indicated for bronchial asthma and for reversible bronchospasm, which may occur with bronchitis and emphysema.

The brand product has annual sales of approximately $44 million.

Source: Teva Pharmaceutical Industries Ltd.

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