Andrx Receives FDA Approvable Letter for Altocor.Business Editors & Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 31, 2002 ANDRX CORPORATION--Andrx Group (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 determined that the marketing 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 ) for Altocor(TM), including labeling, is approvable. Altocor, a lipid lowering agent used in the treatment of elevated cholesterol, utilizes Andrx's proprietary SCOT(TM) controlled-release technology to deliver lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with in a more sustained and consistent manner to the liver, the site of cholesterol synthesis. In controlled clinical trials, Altocor lowered mean LDL-cholesterol by up to 41% with a 60-mg once-daily dose. Altocor also decreases total cholesterol and trigylcerides and increases "good" HDL cholesterol HDL cholesterol n. See high-density lipoprotein. HDL Cholesterol About one-third or one-fourth of all cholesterol is high-density lipoprotein cholesterol. . Results from one Altocor clinical trial were recently published in the January 15, 2002 issue of the American Journal of Cardiology in an article entitled "Dose-Response, Safety and Efficacy of an Extended-Release Formulation of Lovastatin in Adults with Hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. ." Elliot F. Hahn, Ph.D., Andrx's President and Chief Executive Officer, commented: "We are pleased that the United States Food and Drug Administration has completed a successful review of Altocor in only 10 months. The efficacy of our product could address the needs of the great majority of patients with hypercholesterolemia." The United States market for lipid lowering drugs exceeds $10 billion per year and is growing rapidly. Final marketing approval is subject to Andrx's completion of certain conditions set forth in the FDA's letter. 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. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 report 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," "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 detailed in the Company's filings with the Securities and Exchange Commission. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
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