FDA GRANTS "APPROVABLE" STATUS FOR TEVA'S ANDA FOR GABAPENTIN.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, Israel, has announced that the U.S. Food and Drug Administration has granted an "approvable" status for the company's ANDA ANDA abbr. abbreviated new drug application for Gabapentin Capsules 100mg, 300mg and 400mg. Gabapentin Capsules are the generic equivalent of Pfizer's anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this. an·ti·con·vul·sant n. A drug that prevents or relieves convulsions. , Neurontin(R) Capsules. The brand product has annual sales of approximately $1.3 billion. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe. The company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. For more information, call 215/591-8800 or visit http://www.tevapharm.com. |
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