Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), Jerusalem, Isarael, has announced that the U.S. Food and Drug Administration has granted tentative approval for an ANDA for Flumazenil Injection, 0.1 mg/mL, which was submitted by the company's subsidiary SICOR Inc. Final approval of this product is expected upon expiration of patent protection on October 10, 2004.
Flumazenil Injection is the generic equivalent for HLR Technology's Romazicon(R) Injection, a product used to reverse the sedative effects of benzodiazepines.
The brand product has annual sales of approximately $40 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 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.
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