Andrx Receives FDA Approval for Loratadine Orally Disintegrating Tablets.Business Editors/Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nov. 4, 2003 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 its loratadine orally disintegrating tablets 10mg, which are 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 Schering Plough Corporation's Claritin RediTabs(R). This product is labeled for the relief of symptoms of seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. (hay fever hay fever, seasonal allergy causing inflammation of the mucous membranes of the nose and eyes. It is characterized by itching about the eyes and nose, sneezing, a profuse watery nasal discharge, and tearing of the eyes. ) and will be marketed as an over-the-counter product. As previously announced, Perrigo Company, the nation's largest provider of store brand over-the-counter pharmaceuticals, will market Andrx's bioequivalent versions of Claritin products, including Claritin-D(R) 24, Claritin RediTabs and, when approved, Claritin-D(R) 12. Larry Rosenthal, President of Andrx Pharmaceuticals, said: "This marks the approval of the second of our three loratadine products, and we anticipate shipping product to Perrigo before year end. We are pleased with our Perrigo alliance and their success in building store brand share of our generic equivalent of Claritin-D 24. Perrigo is optimistic that together, we can build on this success and position our loratadine RediTabs as the best consumer value on the retail shelf." About Andrx Corporation Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals, using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx also has distribution operations, which purchase primarily generic pharmaceuticals manufactured by third parties and sell them primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and, to a lesser extent, 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 the Company 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 Company'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, including its bioequivalent version of Claritin RediTabs, government regulation, competition, and manufacturing results. 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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