IVAX Receives Generic Drug Approval for Isosorbide Mononitrate Extended-Release Tablets.Business Editors/Health & Medical Writers MIAMI--(BW HealthWire)--Aug. 9, 2001 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX)(LSE LSE - Language Sensitive Editor :IVX.L) received 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) for sales of isosorbide mononitrate extended-release tablets in 30 mg and 120 mg strengths from 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. ). Previously, IVAX received FDA approval for its isosorbide mononitrate extended-release 60 mg tablets. Isosorbide mononitrate is used to treat angina due to coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. and is the generic equivalent of Schering Corporation's Imdur(R) tablets. IVAX will sell this product through its 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. This marks IVAX' sixth generic drug approval so far this year -- with 33 ANDAs and tentative approvals currently 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 pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets. 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 Securities Litigation Reform Act 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 launch isosorbide mononitrate extended-release tablets in 30 mg and 120 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. Imdur(R) is a registered trademark of Schering Corporation. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion