IVAX Receives Final Approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--Sept. 29, 2000 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) received final approval for 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 bisoprolol fumarate and hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema. hy·dro·chlo·ro·thi·a·zide n. Abbr. tablets in 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 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. ). Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension and are the generic equivalent of Lederle Laboratories' Ziac(R) tablets, which have U.S. sales in excess of $200 million. IVAX will market the 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. , 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 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 bisoprolol fumarate and hydrochlorothiazide 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. Ziac(R) is a registered trademark of Lederle Laboratories. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion