Andrx Receives FDA Approvable Letter for its Valproate NDA.Business Editors/Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 14, 2004 Andrx Corporation ("Andrx" or "Company") (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 issued an approvable letter for the Company's new drug application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any "), pursuant to Section 505(b)(2) of the Federal Food Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. , for valproate valproate /val·pro·ate/ (val-pro´at) a salt of valproic acid; the sodium salt has the same uses as the acid. val·pro·ate n. delayed release tablets (125 mg, 250 mg and 500 mg). An approvable letter sets out the conditions that a company must meet in order to obtain FDA final marketing approval. Though Andrx intends to address the requirements of the approvable letter in the near future, the approval and commercial sale of this product are likely to be further delayed as a result of the patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. 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. pending against the Company by Abbott Laboratories. Andrx is seeking approval to market this product for the treatment of manic episodes associated with bipolar disorder, various seizure disorders and prophylaxis of migraine headaches. Andrx's product will compete in the same market as the Depakote(R) family of brand products that had total U.S. sales in 2002 of approximately $1 billion. About Andrx Corporation: Andrx Corporation develops and commercializes: 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. 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 revenue; the timing and outcome of litigation and future product launches, including its valproate product; the timing of and the satisfaction of conditions that the Company must meet in order to obtain FDA final marketing approval for its valproate product and its other products; 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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