Andrx Files ANDA for Toprol-XL.Business Editors/Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 9, 2004 Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or "Company") today announced that it has recently filed an 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 ") with 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. ") for a 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. version of the 50 mg dosage form of Toprol-XL(R) (metoprolol succinate metoprolol succinate Warning - High-alert drug! Toprol-XL (UK) Pharmacologic class: Beta-adrenergic blocker (selective) Therapeutic class: Antihypertensive, antianginal ). AstraZeneca PLC, which markets Toprol-XL, has initiated a patent infringement lawsuit against the Company in the U.S. District Court for the District of Delaware. Andrx believes that it may have been the first ANDA applicant with a Paragraph IV certification for the 50 mg strength, and that it may be entitled to the 180-days of market exclusivity under the Hatch Waxman Amendments for this dose. According to AstraZeneca, Toprol-XL had 2003 U.S. sales of approximately $909 million, of which approximately 45% were for the 50 mg dose. 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 timing and ability to obtain FDA approval of its Toprol XL ANDA, whether such ANDA is entitled to the 180-day exclusivity period, and 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. related thereto, the Company's dependence on a relatively small number of products, licensing revenues, the timing and outcome of litigation and future product launches generally, its ability to obtain FDA approval of its products, government regulation and changes in the law, 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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