Able Laboratories Receives FDA Approval for Phentermine Hydrochloride Capsules, USP 15mg; Approval Completes Able's Line of Phentermine Products.Business Editors/Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--March 13, 2003 Able Laboratories, Inc. (Nasdaq: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 it 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 Phentermine phentermine /phen·ter·mine/ (fen´ter-men) a sympathomimetic amine related to amphetamine, used as an anorectic either as the hydrochloride salt or as the base complexed with an ion exchange resin. HCI Capsules, USP USP - unique sales point 15mg. This product is equivalent to Phentermine Hydrochloride Capsules, USP 15mg of EON Labs Inc. The total market for Able's newly approved drug (used in the treatment of obesity) is estimated to be approximately $8 million according to recent 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. This approval, along with Able's Phentermine Hydrochloride Tablets, USP 37.5mg, Phentermine Hydrochloride Capsules, USP 30mg (beads) and Phentermine Hydrochloride Capsules, USP 30mg (powder), represents the completion of Able's line of Phentermine-based products. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 25 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 operations and growth, the current or expected market size for the Company's products, the adequacy of the Company's manufacturing capacity, the availability of sufficient capital, 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 Annual Report on Form 10-K for the year ended December 31, 2001 and its Form 10-Q for the nine months ended September 30, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. |
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