Andrx Announces Approval of Metformin HCl Extended-Release Tablets, 750mg.FORT LAUDERDALE, Fla. -- Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. has granted final approval of its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar for 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: extended-release tablets, 750mg. Andrx has already commenced shipping this product. Andrx's metformin HCl metformin HCl (metfor´min), n brand name: Glucophage; drug class: oral hypoglycemic, biguanide derivative; action exact mechanism unknown, requires insulin secretion to function properly; use: type II diabetes mellitus. ER tablets, 750mg, are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage(R) XR Tablets, 750mg, a product indicated for the treatment of type 2 diabetes type 2 diabetes n. See diabetes mellitus. . About Andrx Corporation We are a pharmaceutical company that develops, manufactures and commercializes generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives. We also distribute pharmaceuticals, primarily generics, which have been commercialized by others, as well as our own, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the 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. For this purpose, any statements contained herein or which are otherwise made by or on behalf of Andrx that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the commercial success of Andrx's generic metformin hydrochloride extended-release tablets, 750mg product, Andrx's dependence on a relatively small number of products, licensing revenues, the timing and outcome of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and future product launches, government regulation, competition, and manufacturing capacities, safety issues, output and quality processes. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com. |
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