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Andrx Scales-Up Generic Ortho Cyclen-28 Tablets.


Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 13, 2004

Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that it has now completed the scale-up of Previfem(TM) Tablets (Norgestimate and Ethinyl Estradiol eth·i·nyl estradiol
n.
A synthetic estrogen derivative commonly used in oral contraceptives.


Ethinyl estradiol 
, 0.18mg/0.035 mg.), an oral contraceptive oral contraceptive
n.
A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill.
 product which is 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 Ortho Cyclen-28(R), and was approved for sale by 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.
) on January 9, 2004. Andrx and Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd., with whom the Company has entered into a strategic collaboration, are presently working towards the commercialization of Previfem Tablets as well as Tri-Previfem(TM) Tablets, the Company's generic version of Ortho Tri-Cyclen(R). The Company's 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 Ortho Tri-Cyclen was tentatively approved by the FDA on January 6, 2004, and cannot receive final FDA approval until March 26, 2004. Both Ortho Cyclen-28 and Ortho Tri-Cyclen are Ortho McNeil Pharmaceutical, Inc. products.

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 which do not maintain their own central warehousing facilities, 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 revenues; the timing of FDA approvals for the Company's ANDAs; the successful scale-up of Tri-Previfem Tablets; the successful timing and commercial success of future product launches, including Previfem Tablets and Tri-Previfem Tablets; 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.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jan 13, 2004
Words:477
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