Andrx Comments On Prilosec ANDA Filing.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nov. 21, 2000 ANDRX CORPORATION - ANDRX GROUP (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today commented, in response to numerous investor calls, on the status 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 a 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. version of Prilosec(R). As first announced publicly on April 20, 1998, Andrx continues to understand and to believe that its ANDA for a bioequivalent version of Prilosec was the first to be accepted for filing 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. "). As such, Andrx expects that its product will receive 180-days of market exclusivity. First to file status is based solely upon which ANDA having a Paragraph IV certification was the first to be accepted for filing by the FDA. This status is neither "granted" nor commented on by the FDA until final marketing approval is granted. The Andrx ANDA for Prilosec(R) was accepted for filing on March 17, 1998 and was tentatively approved on March 23, 2000. Andrx anticipates receiving final marketing approval following the expiration of AstraZeneca's composition of matter patent. Many investors have called to advise that, at an investor conference last week, Astra representatives declined to answer questions as to whether the Andrx ANDA was the first to be filed. Rather than understanding that Astra is legally prohibited from disclosing or commenting on confidential information it receives in the Prilosec(R) 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. , including the relative dates in which the Andrx ANDA and other ANDAs were accepted for filing, Astra's non-answer has mistakenly been viewed as a statement that the Andrx ANDA was not the first accepted for filing by the FDA. 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, words such as "may," "will," "to", "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or 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. Andrx is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation's filings with the Securities and Exchange Commission, including Andrx Corporation's Annual Report on Form 10-K for the year ended December 31, 1999. This release and additional information about Andrx Group and Andrx Corporation are also available at http://www.andrx.com |
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