IVAX Receives Final FDA Approval for Anagrelide HCl Capsules.MIAMI -- IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) (WSE:IVX) has received 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 anagrelide HCl capsules in 0.5 and 1 mg dosage strengths. This product will be sold through IVAX' 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. Anagrelide HCl capsules is the generic equivalent of Agrylin(R) Capsules, which is marketed by Shire U.S., Inc. for thrombocythemia, a condition in which there are too many platelets in the blood, resulting in bleeding, blood clots, enlarged spleen, or stroke. According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, U.S. sales of anagrelide HCl capsules, 0.5 and 1 mg, were $105 million during 2004. 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 http://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' generic products, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of anagrelide HCl capsules in 0.5mg and 1mg strengths may 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. Agrylin(R) is a registered trademark of Shire U.S., Inc. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion