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Able Laboratories Receives FDA Approval for Two Additional Formulations of Promethazine HCL Suppositories, USP
Business Wire, April 14, 2003
Business Editors/Health/Medical Writers
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--April 14, 2003
Only Company to Offer AB-Rated Generic Versions of All Three Strengths
of Phenergan(R) Suppositories
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 HCL Suppositories, USP 12.5mg and 25mg, which are equivalent to Phenergan(R) Suppositories, USP 12.5mg and 25mg, respectively, of Wyeth-Ayerst Laboratories. The total market for Able's newly approved drugs (used in the treatment of allergies, anaphylactic reaction, pre/post-operative sedation, nausea and vomiting) is estimated to be approximately $104 million according to recent market data.
This approval, along with Able's Promethazine HCL Suppositories, USP 50mg, represents the completion of Able's line of Promethazine-based suppository products. In addition, this allows Able to be the only company to offer AB-rated generic versions of all three strengths (50mg, 25mg and 12.5mg) of Phenergan(R) suppositories.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 27 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 cost of capital and the availability of sufficient capital resources, operations and growth, the current or expected market size for the Company's products, the adequacy of the Company's manufacturing capacity, 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 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.
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