IVAX to Market Tramadol.Business Editors/Health & Medical Writers MIAMI--(BUSINESS WIRE)--Jan. 28, 2002 IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) announced today that the 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 the brand equivalent (generic) drug tramadol hydrochloride tablets in 50 mg strength has been transferred to 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., from Able Laboratories, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ABRX). Under an agreement, IVAX will exclusively purchase the product from Able Laboratories and market the tramadol hydrochloride tablets under its own label. Other terms were not disclosed. Previously, Able Laboratories received notification 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. ) that its ANDA for tramadol hydrochloride tablets is approvable. Final approval is subject to resolution of labeling issues. IVAX anticipates launching this product in about one month. Tramadol is used to treat persistent moderate to severe pain and is the generic equivalent of Ultram(R) Tablets with annual estimated sales of approximately $550 million. IVAX currently has 38 ANDAs and four tentative approvals pending at the FDA and 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 products in the U.S. and international markets. Copies of this and other news releases may be obtained free of charge from IVAX' Web site 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' 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 may not receive final approval for tramadol hydrochloride tablets in 50 mg strength or that its launch will be delayed; that IVAX many 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. Ultram(R) Tablets is a registered trademark of R.W. Johnson Pharmaceutical Research Institute. |
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