Able Laboratories, Inc. Receives Two FDA Approvals for Three Formulations of Hydrocodone Bitartrate and Acetaminophen Tablets, USP.Business Editors & Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Oct. 24, 2002 Able Laboratories, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ABLA ABLA Asia Business Leader Awards ABLA American Belgian Laekenois Association ABLA American Blind Lawyers Association ABLA American Business Law Association ABLA Asheville Business Leaders Association (Asheville, NC) ) (BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). :AAB), today announced 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 Applications (ANDAs) for Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen Warning - High-alert drug! Anexsia, Ceta-Plus, Co-Gesic, Hydrocet, Lorcet-HD, Lortab, Vicodin, Vicodin HP Pharmacologic class: Tablets, USP USP - unique sales point 7.5 mg/ 325 mg, Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/ 325 mg and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/ 650 mg. These products are equivalent to the Noroco(R) of Watson Laboratories and Hydrocodone Bitartrate and Acetaminophen Tablets, USP of Mikart Inc., respectively. The total combined generic and brand market for Able's newly approved drugs, used for the relief of moderate to severe pain, is estimated to be $300 million. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 18 ANDA ANDA abbr. abbreviated new drug application 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, capital-raising transactions and financial accounting, the current or expected market size for its products, the success of current or future product offerings, the 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 achieve the sales levels that will 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 six months ended June 30, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. |
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