Able Laboratories, Inc. Receives Two FDA Approvals for Acetaminophen and Codeine Phosphate Tablets, USP.Business Editors & Health/Medical Writers SOUTH PLAINFIELD, N.J.--(BW HealthWire)--Aug. 2, 2002 Generic Version of Tylenol(R) With Codeine codeine (kō`dēn), alkaloid found in opium. It is a narcotic whose effects, though less potent, resemble those of morphine. An effective cough suppressant, it is mainly used in cough medicines. Like other narcotics, codeine is addictive. #3 With Estimated Total Market of $144 Million; Generic Version of Tylenol(R) With Codeine #4 With Estimated Total Market of $56 Million 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 Acetaminophen and Codeine Phosphate Tablets, USP USP - unique sales point 300 mg/ 30 mg and Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/ 60 mg. These products are equivalent to the Tylenol(R) with Codeine #3 and Tylenol(R) with Codeine #4 of R.W. Johnson. The total combined generic and brand market for Able's newly approved drugs, used in the treatment of mild relief of severe pain, is estimated to be $200 million according to the 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. Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 16 ANDA approvals. The Company has completed its transition to focus its activities on generic drug development, manufacturing and sales. 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 three months ended March 31, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments. Note to Editors: Tylenol is a registered trademark of R.W. Johnson. |
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion