Able Laboratories Receives FDA Approval for Metronidazole Tablets USP, 250mg and 500mg.Business Editors/Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--June 27, 2003 ABLE LABORATORIES, INC. (Nasdaq NMS See NetWare Management System. : ABRX, BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). : AAB), today announced that it has received 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. ) approval 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 ANDA abbr. abbreviated new drug application ) for Metronidazole metronidazole /met·ro·ni·da·zole/ (-ni´dah-zol) an antiprotozoal and antibacterial effective against obligate anaerobes; used as the base or the hydrochloride salt. It is also used as a topical treatment for rosacea. Tablets USP USP - unique sales point , 250mg and 500mg, which is therapeutically equivalent to Flagyl(R) Tablets USP, 250mg and 500mg, of G.D. Searle LLC. The total market for Able's newly approved drugs (used in the treatment of women with bacterial vaginosis B.V.) is estimated to be approximately $60 million according to recent market data. On Wednesday, June 25, 2003, the Company announced that it received FDA approval for its ANDA for Metronidazole Extended-Release Tablets, 750mg. The Company's ANDA for Metronidazole capsules, 375mg, is pending approval at the FDA. With this pending approval, Able will be the only company offering a complete line of Metronidazole formulations. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 31 ANDA approvals. Further information on Able may be found on the Company's web site, www.ablelabs.com. Except for historical facts, the statements in this news release, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., are forward-looking statements within the meaning 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 and involve risks and uncertainties. For example, statements about the Company's cost of capital and the availability of sufficient capital resources, operations and growth, the current or expected market size for the Company's products, the adequacy of the Company's manufacturing capacity, the success of current or future product offerings, research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will continue to achieve the sales levels necessary to make its operations profitable or that ANDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2003 and its Annual Report on Form 10-K for the year ended December 31, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. |
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