Able Laboratories Receives FDA Approval for Promethazine Hydrochloride Suppositories, USP 50mg; First AB-Rated Generic Version of Wyeth-Ayerst Phenergan 50mg Suppository

Business Wire, Feb 28, 2003

Business Editors/Health/Medical Writers

SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Feb. 28, 2003

Able Laboratories, Inc. (Nasdaq:ABRX) (BSE:AAB), today announced that it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Promethazine Hydrochloride Suppositories, USP 50mg. This product is equivalent to Phenergan(R) Suppositories, USP 50mg of Wyeth-Ayerst Laboratories. The total market for Able's newly approved drug (used in the treatment of allergies, anaphylactic reaction, pre/post-operative sedation, nausea and vomiting) is estimated to be approximately $7 million according to recent IMS data.

This represents the first generic AB-rated Promethazine Hydrochloride Suppository, USP 50mg available to the market.

Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 24 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 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 nine months ended September 30, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.