IVAX Announces Generic Drug Approval for Isosorbide Mononitrate Extended-Release Tablets.Business Editors MIAMI--(BUSINESS WIRE)--June 23, 2000 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) today announced 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 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 approved 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 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) 60 mg tablets. IVAX will begin marketing the product in the near future through its wholly-owned subsidiary, Zenith Goldline Pharmaceuticals, Inc. IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacturing, and marketing of branded and generic 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 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. Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risk that Zenith Goldline Pharmaceuticals will not launch isosorbide mononitrate extended-release tablets or that its launch will be delayed, and certain other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's 1999 annual report on form 10-KA and its other filings with the Securities and Exchange Commission. Imdur(R) is a registered trademark of Schering Corporation. |
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