Able Laboratories Receives FDA Approval for Lithium Carbonate Extended-Release Tablets, USP 300mg.Business Editors/Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--April 22, 2003 Company Anticipates to Be the First to Ship Generic Version of Lithobid(R) Slow-Release Tablets, USP USP - unique sales point 300mg Able Laboratories, Inc. (Nasdaq:ABRX) (BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). :AAB AAB ABN Amro Bank AAB Association of Applied Biologists (UK) AAB American Association of Bioanalysts AAB Army Air Base AaB Aalborg Boldspilklub (Danish Soccer Club) AAB All-to-All Broadcast ), 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 Lithium Carbonate Extended-Release Tablets, USP 300mg, which is therapeutically equivalent to Lithobid(R) Slow-Release Tablets, USP 300mg, of Solvay Pharmaceuticals, Inc. The total market for Able's newly approved drug (used in the treatment of episodes of manic depressive illness Noun 1. manic depressive illness - a mental disorder characterized by episodes of mania and depression bipolar disorder, manic depression, manic-depressive psychosis ) is estimated to be approximately $27 million according to recent market data. Although Able is the second company to receive an ANDA approval for this product, Able anticipates it will be the first company to ship the generic equivalent of Lithobid(R) Slow-Release Tablets. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 28 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 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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