You are here
FDA Approves Indomethacin Capsules in 25-, 50-mg Doses
SOUTH PLAINFIELD, N.J., Dec. 18 /PRNewswire-FirstCall/ -- ABLE LABORATORIES, INC. , today announced that it has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Indomethacin Capsules, USP 25mg and 50mg, which 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 75mg, in February 2002, represents the completion of Able's line of Indomethacin-based products.
Source: Able Laboratories, Inc.