Teva Announces Approval of Glipizide and Metformin HCL Tablets.JERUSALEM -- 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) today announced that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA ANDA abbr. abbreviated new drug application for Glipizide and Metformin Hydrochloride metformin hydrochloride Warning - High-alert drug! Apo-Metformin (CA), Fortamet, Glucophage, Glucophage XR, Glycon (CA), Metsol (UK), Novo-Metformin (CA), Riomet Pharmacologic class: Tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg. Shipment of this product will begin immediately. Teva's Glipizide and Metformin Hydrochloride Tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Metaglip(R) Tablets, which are indicated as an adjunct to diet and exercise in type 2 diabetes type 2 diabetes n. See diabetes mellitus. , as initial therapy or as a second-line therapy when response to sulfonylurea sulfonylurea /sul·fo·nyl·urea/ (sul?fo-nil-u-re´ah) any of a class of compounds that exert hypoglycemic activity by stimulating the islet tissue to secrete insulin; used to control hyperglycemia in patients with type 2 diabetes mellitus or metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus. met·for·min n. is inadequate. The brand product has U.S. annual sales of approximately $37 million. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 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 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. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the U. S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: This release contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include whether and when the proposed acquisition with Ivax Corporation IVAX Corporation was a United States public corporation focused on manufacturing and distributing generic pharmaceutical products. Ivax was acquired by the Israeli company Teva Pharmaceutical Industries in January 2006. External links
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