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Able Laboratories, Inc.
FDA grants approval for Indomethacin capsules
January 14th, 2004
Able Laboratories, Inc., (ABRX), announced that it has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Indomethacin capsules, USP 25 mg and 50 mg. Indomethacin is therapeutically equivalent to Indocin capsules, 25mg and 50mg, of Merck Research Laboratories. The total market for Able's newly approved drug (used in the treatment of rheumatoid arthritis, osteoarthritis, bursitis, and tendonitis) is estimated to be approximately $7 million according to recent market data. This approval, along with Able's approvals of Indomethacin extended release capsules, USP 75 mg, in...
Source: Biotech Week (2004-01-14)
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