IVAX Receives Final Approval for Buspirone.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--March 1, 2002 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) reported that it has received final 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. approval for 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 ) and has started marketing its buspirone hydrochloride tablets in 5 mg, 10 mg and 15 mg strengths through the company's wholly owned subsidiary Wholly Owned Subsidiary 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. Buspirone hydrochloride is the generic equivalent of Bristol-Myers Squibb Company's Buspar(R) and is used in the management of anxiety disorders. U.S. sales of branded and generic buspirone hydrochloride were approximately $630 million during the past year. IVAX currently has 36 ANDAs and two tentative approvals pending at the FDA. The company 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 (generic) 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. Shareholders and prospective investors can register to automatically receive the company's press releases via email at http://www.ivax.com/ComNewsv2.htm. The "FDA" refers to 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. . 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 related to changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; 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. Buspar(R) is a registered trademark of Bristol-Myers Squibb Company. |
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