Andrx Granted Temporary Restraining Order Regarding Generic Wellbutrin SR 100 mg Tablets

Business Wire, Dec 3, 2003

Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Dec. 3, 2003

Andrx Corporation (Nasdaq:ADRX) announced that a Magistrate Judge for the United States District Court for the Southern District of Florida has issued a report and recommendations with respect to the Company's motion for a temporary restraining order preventing the Food and Drug Administration (FDA) from granting final approval of Eon Labs, Inc.'s (Eon) abbreviated new drug application (ANDA) for extended release Bupropion Hydrochloride, 100 mg tablets, which is bioequivalent to Wellbutrin(R) SR. The report and recommendations "finds that there is a sufficient basis for the issuance of a temporary restraining order" preventing the approval of Eon's or anyone else's ANDA for such 100 mg product and Eon's marketing of such product until further order of the court, and sets forth a briefing schedule for this matter. The report and recommendations is currently effective, but is subject to review by the US District Judge. Eon, on November 26, 2003, announced that the FDA had approved its ANDA for this product and that it planned to begin shipping its bupropion product immediately. Believing that it was the first-to-file an ANDA for this product, and therefore entitled to the 180-day market exclusivity period provided by law, Andrx filed its lawsuit and sought the issuance of this restraining order.

This temporary restraining order is separate from, and in addition to, the temporary restraining order reportedly entered by a court in New York, in connection with Eon's ongoing patent infringement litigation with GlaxoSmithKline. Andrx is not a party to such litigation.

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, 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, when or whether the Andrx ANDAs for Wellbutrin SR and Zyban will receive FDA final marketing approval and/or its products will be launched, whether such ANDAs will be deemed the first to file and be awarded market exclusivity, the Company's dependence on a relatively small number of products, licensing revenues, the timing and outcome of litigation and future product launches, 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.