IVAX Receives Tentative Approval for Lisinopril.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--Dec. 21, 2001 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE:IVX.L) announced today that 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) has given tentative approval to 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) for lisinopril tablets in 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg strengths. Lisinopril is used to treat hypertention, heart failure and acute myocardial infarction acute myocardial infarction ( A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , IVAX Pharmaceuticals, Inc. immediately following expiration of the pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. exclusivity period for the branded drug on June 29, 2002. IVAX currently has 32 ANDAs and 4 tentative approvals pending at the FDA and is continuing its aggressive filing schedule for new ANDA submissions. IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent pharmaceuticals and veterinary products in the U.S. and international markets. Copies of this and other news releases may be obtained free of charge from IVAX' Web site at http://www.ivax.com. Except for the historical matters contained herein, statements in this press release are forward-looking and 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. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' pending ANDAs and tentative approvals and filing schedule for ANDA submissions, involve risks and uncertainties which may affect the company's business and prospects, including the risks that IVAX Pharmaceuticals may not receive final approval for lisinopril tablets in 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg strengths or that its launch will be delayed; that IVAX may not receive approval of its pending ANDAs or final approval of its tentatively approved ANDAs, or that if approved, the products will not be successfully commercialized; that IVAX may not file any additional ANDAs; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's 2000 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Zestril(R) Tablets is a registered trademark of AstraZeneca. |
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