Able Laboratories Receives FDA Approval for Naproxen Sodium Tablets, USP 275 mg (250 mg base) and 550 (500 mg base)
Monday August 25, 6:00 am ET
Company Receives Approval for Generic Version of Anaprox(R) Tablets, 275 mg (250 mg base) and Anaprox(R) DS Tablets, 550 mg (500 mg base)
SOUTH PLAINFIELD, N.J., Aug. 25 /PRNewswire-FirstCall/ -- ABLE LABORATORIES, INC. (Nasdaq: ABRX - News; BSE: AAB - News), today announced that it has received Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Naproxen Sodium Tablets, USP 275 mg (250 mg base) and 550 (500 mg base), which is therapeutically equivalent to Anaprox® Tablets, 275 mg (250 mg base) and Anaprox® DS Tablets, 550 mg (500 mg base) of Roche Palo Alto LLC. Able's newly approved drug is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis, tendonitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. The total annual market is estimated to be approximately $22 million according to recent market data.
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Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 33 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 research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, cost of capital and the availability of sufficient capital resources, operations and growth, the adequacy of the Company's manufacturing capacity and its plans for expanding its operations, the current or expected market size for the Company's products, and the success of current or future product offerings, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events. These 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 Form 10-Q for the quarter ended June 30, 2003 and 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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