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Andrx Receives FDA Approval for Generic Tiazac; Launch Underway.


Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 10, 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 the 120 mg., 180 mg., 240 mg., 300 mg., and 360 mg. strengths of its Diltiazem Hydrochloride dil·ti·a·zem hydrochloride
n.
A calcium channel blocking agent used to dilate coronary blood vessels.


diltiazem hydrochloride 
 Extended-release Capsules that 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 Tiazac(R). To be marketed under the name Taztia(TM), this product is a calcium channel blocker calcium channel blocker
n.
Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders.
 indicated for the treatment of hypertension and chronic stable angina chronic stable angina Cardiology The most common form of angina, characterized by chest discomfort due to myocardial ischemia, and unaccompanied by myocardial necrosis; the cause of pain is uncertain, possibly substances released during transient ischemia–eg, . Tiazac is manufactured by Biovail Corporation, marketed by Forest Laboratories, Inc., and had 2002 U.S. sales of $270 million.

Richard J. Lane, Andrx's Chief Executive Officer, remarked: "I am exceedingly pleased to announce this approval which we have anticipated receiving for a long time. Although we have maintained that our product was bioequivalent and stable, receiving final FDA approval ends all speculation. Simultaneous with this final marketing approval, we plan to launch all strengths of Taztia. We believe that Taztia will be a significant contributor to Andrx's 2003 operating results."

Though FDA awarded Andrx's ANDA a 180-day period of marketing exclusivity, that exclusivity period has expired.

About Andrx

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 utilize telemarketing sales representatives to sell these products, as well as its own, primarily to independent pharmacies, pharmacy chains that do not maintain their own central warehousing facilities, pharmacy buying groups and, to a lesser extent, physicians' offices.

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 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," "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 but not limited to, Andrx's ability to manufacture Taztia and its market acceptance, as described herein, as well as Andrx's results of operations. Andrx is also subject to other risks as detailed from time-to-time in the Company's filings with the Securities and Exchange Commission.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 10, 2003
Words:480
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