Able Laboratories Inc has received Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Butalbital Acetaminophen Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30mg, which is therapeutically equivalent to Fioricet with Codeine Capsules of Watson Pharmaceuticals Inc.
Able's newly approved drug is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. The total market is estimated to be approximately $20 million according to recent market data.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 32 ANDA approvals.