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Able Laboratories Receives ANDA Approval for Tramadol Hydrochloride Tablets; Generic Version to be Marketed by IVAX Pharmaceuticals

Business Wire, July 3, 2002

Business Editors & Health/Medical Writers

Able Laboratories, Inc. (OTCBB:ABLA) (BSE:ABRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Tablets, 50mg. The total market for Able's newly approved drug, an AB-rated generic version of R.W. Johnson's Ultram(R), is approximately $550 million according to the IMS Data.

Earlier in the year, Able Labs announced that it entered into an ANDA Transfer and Marketing Agreement with IVAX Pharmaceuticals, Inc. a wholly owned subsidiary of IVAX Corporation (AMEX:IVX) (LSE:IVX.L) for Able Labs' Tramadol Hydrochloride Tablets. Under the terms of the agreement, Able Labs will manufacture and supply the product exclusively to IVAX under their label and IVAX will exclusively sell Able Labs' manufactured product.

Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 14 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 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.

COPYRIGHT 2002 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning
 

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