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.

More Headlines

First and Only Treatment Reduces Depressive Symptoms Within Days
Bone Marrow Cleared of Leukemia in Almost 60% of Patients
Combination of Two Drugs Could Reduce Tumor Growth
PARG Inhibitor Exploits Weakness, Kills Cells
Inexpensive, Wearable Therapy Increases Arm Mobility, Reduces Stiffness
Atezolizumab in Combination with Chemotherapy is the Only First-line Cancer Immunotherapy for ES-SCLC
Pre-clinical Trials Showed Drug Inhibits Fibroblast Activity and Collagen Deposition
National Statistics Report Factors In Race, Ethnicity for the First Time