IVAX Receives Final Approval On Benazepril HCl/HCTZ Tablets.Business Editors/Health/Medical Writers MIAMI--(BUSINESS WIRE)--Feb. 13, 2004 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) has received a final approval from the U.S. Food and Drug Administration (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. ) 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 Benazepril Hydrochloride (HCl) plus Hydrochlorothiazide (HCTZ HCTZ abbr. hydrochlorothiazide ) tablets in the same strengths as the brand, 5/6.25 mg, 10/12.5 mg, 20/12.5 mg and 20/25 mg. This product will be sold 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. Benazepril HCl/HCTZ is the generic equivalent of Lotensin HCT(R), which is marketed by Novartis for the treatment of hypertension (but is not indicated for the initial therapy of hypertension). U.S. sales of Lotensin HCT in 5/6.25, 10/12.5, 20/12.5, and 20/25 dosage strengths were over $80 million for 2003. IVAX continues its aggressive program to increase the number of products in its generic portfolio. IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally. Copies of this and other news releases may be obtained free of charge from IVAX' website at 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' aggressive program to increase the number of products in its generic portfolio, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of Benazepril HCl/HCTZ tablets in 5/6.25 mg, 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths will be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Lotensin HCT(R) is a registered trademark of Novartis. |
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