FDA GRANTS TENTATIVE APPROVAL OF SICOR'S FLUMAZENIL INJECTION.Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (Nasdaq: TEVA), Jerusalem, Isarael, has announced that the U.S. Food and Drug Administration has granted tentative approval for an ANDA ANDA abbr. abbreviated new drug application for Flumazenil Injection, 0.1 mg/mL, which was submitted by the company's subsidiary SICOR SICOR Single Intelligence Correlator 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 (Home Location Register) A database in a cellular system that contains all the subscribers within the provider's home service area. When a subscriber reaches a new service area, the data in the HLR is requested and transferred via SS7 to the VLR (Visitor Location Technology's Romazicon(R) Injection, a product used to reverse the sedative effects of benzodiazepines Benzodiazepines Definition Benzodiazepines are medicines that help relieve nervousness, tension, and other symptoms by slowing the central nervous system. Purpose Benzodiazepines are a type of antianxiety drugs. . 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. For more information, call 215/591-8800. |
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