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Generic Anaprox Tablets Approved by FDA
SOUTH PLAINFIELD, N.J., Aug. 25 /PRNewswire-FirstCall/ -- ABLE LABORATORIES, INC. , 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.
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, http://www.ablelabs.com/.