Teva Pharmaceutical Industries Ltd announced that the US 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 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.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.