Able Laboratories Receives FDA Approval for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg; Approval Completes Able's Line of Hydrocodone Products

Business Wire, May 23, 2003

Business Editors/Health/Medical Writers

SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--May 23, 2003

ABLE LABORATORIES, INC. (Nasdaq NMS:ABRX, BSE:AAB) today announced that it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg.

This product is equivalent to Lortab(R) Tablets, USP 7.5mg/500mg of Mikart, Inc. The total market for Able's newly approved drug (used for the relief of moderate to moderately severe pain) is estimated to be approximately $230 million according to recent market data.

This approval, along with Able's eight other Hydrocodone Bitartrate and Acetaminophen Tablet products, represents the completion of Able's line of Hydrocodone-based products.

Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 29 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 of 1995 and involve risks and uncertainties. For example, statements concerning 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 Quarterly Report on Form10-Q for the quarter ended March 31, 2003 and 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.