Ivax Corporation has received final FDA approval for its Abbreviated New Drug Application (ANDA) for nabumetone tablets in 500 mg and 750 mg strengths. Ivax will immediately begin to market nabumetone through its wholly owned subsidiary, Ivax Pharmaceuticals Inc. Nabumetone is a nonsteroidal anti-inflammatory drug used in the treatment of osteoarthritis and rheumatoid arthritis. It is the generic equivalent of GlaxoSmithKline's Relafen. U.S. sales of branded and generic nabumetone were approximately $205 million during the past year.
Ivax currently has 37 ANDAs and two tentative approvals pending at the FDA. The company is continuing its aggressive filing schedule for new ANDA submissions.