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Able Laboratories Receives FDA Approval for Methocarbamol Tablets, USP 500mg and 750mg
Business Wire, March 18, 2003
Business Editors/Health/Medical Writers
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--March 18, 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 Methocarbamol Tablets, USP 500mg and 750mg. This product is equivalent to Robaxin(R) Tablets, 500mg and Robaxin(R)-750 Tablets, 750mg of Schwarz Pharma, Inc. (formerly A.H. Robins). The total market for Able's newly approved drug (used in the relief of discomfort associated with acute painful musculoskeletal condition) is estimated to be approximately $65 million according to recent IMS data.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 26 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 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 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.
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