Andrx Issues Update On Its ANDA for Generic Prilosec.Business Editors & Health/Medical Writers FORT LAUDERDALE Fort Lauderdale (lô`dərdāl), residential, commercial, and resort city (1990 pop. 149,377), seat of Broward co., SE Fla., on the Atlantic coast; settled around a fort built (c.1837) in the Seminole War, inc. 1911. , Fla.--(BUSINESS WIRE)--Oct. 4, 2001 Andrx Corporation -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) announced today that the 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, for the first time, advised Andrx that, in order to address certain issues related to omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with raised by AstraZeneca ("Astra") working together with aai Pharma, Inc. ("aai"), final marketing approval of Andrx's ANDA ANDA abbr. abbreviated new drug application for a generic version of Prilosec(R) may be delayed. The FDA indicates that it is currently addressing these issues. Andrx believes that the FDA has also advised each of the other ANDA applicants for Prilosec of these issues raised by Astra and aai. Astra first began communicating with the FDA about these issues on April 10, 2000, which it supplemented with letters dated July 5, 2001. Just a few days later, when the aai patents were issued, Astra publicly claimed to have only just learned about them. The possible delay by the FDA should have no effect on the trial of the infringement litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. between Astra and Andrx, which was transferred earlier this week to the Southern District of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of and is awaiting the scheduling of a date for trial. Marketed by Astra, Prilosec is reputed to be the largest selling pharmaceutical product in both the United States and the world. Andrx had anticipated receiving final marketing approval of its tentatively approved ANDA for certain strengths of this product on or shortly after October 5, 2001. "Andrx believes that exposure to anti-trust liability deterred Astra and aai from listing aai's patents in the Orange Book and suing Andrx, which could have further delayed approval of Andrx's ANDA," said Andrx President, Elliot F. Hahn, Ph.D. "Instead, they and others in the pharmaceutical industry are now suggesting by innuendo innuendo n. from Latin innuere, "to nod toward." In law it means "an indirect hint." "Innuendo" is used in lawsuits for defamation (libel or slander), usually to show that the party suing was the person about whom the nasty statements were made or why the comments to the FDA that certain concerns may exist with regard to generic products, but not to their own. Andrx is firm in its belief that these latest moves are merely transparent ploys to prevent or delay introduction of generics. We are confident that the FDA, Congress and consumers will quickly see through these latest smokescreens." Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative 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. Contact: Elliot F. Hahn, Ph.D., President of Andrx Corporation, 4955 Orange Drive, Davie, FL 33314, 954-584-0300. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
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