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Andrx Granted FDA Tentative Approval For Generic Nolvadex.


Business Editors & Health/Medical Writers

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 tentatively 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 10 mg and 20 mg tamoxifen citrate tablets USP USP - unique sales point , which are bioequivalent to Nolvadex(R). Marketed by Astrazeneca Pharmaceuticals LP, Nolvadex is used in the treatment of breast cancer. Nolvadex, and a licensed generic version thereof, are presently being marketed, and had combined 2001 product sales of approximately $515 million.

Andrx Chief Executive Officer, Richard J. Lane, commented: "This is the second of our generic products to receive FDA tentative approval in the past two weeks. We are pleased that our products are continuing to work their way through the regulatory system, in anticipation of their launch."

A tentative approval indicates that FDA has made an initial determination that the application for a generic drug satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed periods during which approval cannot be granted. Final marketing approval is required for the applicant to market the generic drug. The earliest Andrx's generic version of Nolvadex could receive FDA final marketing approval is February 20, 2003, as U.S. patent No. 4,536,516, which covers Nolvadex and which includes a pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 extension, is scheduled to expire on that date.

About Andrx

Andrx Corporation is a specialty pharmaceutical company engaged in the commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Andrx also distributes generic pharmaceutical products manufactured by third parties.

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, there can be no assurance as to when or whether the Andrx ANDA for Nolvadex will receive final marketing approval from the FDA, and 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 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
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 16, 2002
Words:419
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