Andrx Gains FDA Tentative Approval for Generic Ortho Tri-Cyclen.

Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Jan. 8, 2004

Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has tentatively approved the Company's Abbreviated New Drug Application ("ANDA") for Ortho Tri-Cyclen(R) (norgestimate/ethinyl estradiol) tablets, an Ortho-McNeil Pharmaceutical, Inc. oral contraceptive product. The Andrx ANDA is for 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg strengths, packaged in 28-day cycle regimens. According to the FDA's letter, pediatric exclusivity was granted for this product, thereby extending the effective expiration date of the patents pertaining to this product until March 26, 2004.

The Company has received inquiries regarding the January 7, 2004 update of new drug approvals issued by CDER (Center for Drug Evaluation and Research), which included Andrx's Norgestimate and Ethinyl Estradiol Tablets, without additional details. Andrx has advised FDA of the confusion resulting from this update, and the FDA has indicated that a correction has been or soon will be made.

As previously announced, Andrx has entered into a strategic collaboration with Teva Pharmaceutical Industries Ltd., whereby Teva has received exclusive marketing rights in the U.S. and Canada to Andrx's entire line of generic oral contraceptive products currently pending approval at the FDA, including Andrx's ANDA for Ortho Tri-Cyclen tablets.

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 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, including Ortho Tri-Cyclen; the successful scale-up, timing and commercial success of future product launches, including Ortho Tri-Cyclen; 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.