Andrx Granted FDA Final Marketing Approval for Naprelan.Business Editors & Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 28, 2002 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. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved the marketing 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 (ANDA ANDA abbr. abbreviated new drug application ) for a 500-mg strength of naproxen sodium, a non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. , which is bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Naprelan(R). Marketed by Elan Corporation, the 500-mg strength of Naprelan had 2001 brand sales of approximately $25 million. Naprelan is used for the treatment of pain caused by arthritis, osteoporosis and other inflammatory conditions. Andrx plans to begin marketing its generic version of Naprelan in September 2002. Larry Rosenthal, Andrx Pharmaceuticals' Executive Vice President of Sales and Marketing said, "We are proud to announce another first for Andrx and we are hopeful that this represents the start of an exciting second half of the year." Andrx also has a 375-mg generic version of Naprelan, which has FDA tentative approval. As the 30-month period for the 375-mg strength of Naprelan will not expire until December 2002, absent a final and unappealable court decision in the Company's pending patent dispute with Elan, FDA is unable to grant final approval of the 375-mg strength of the Andrx product until that time. About Andrx Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Andrx also markets and distributes pharmaceutical products manufactured by third parties. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com. 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 in this release 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," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties, including but not limited to, the commercial launch and approval of the products described herein and Andrx's results of operations. The Company is also subject to other risks as detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. |
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