Merck Re-Submits Arcoxia Application After FDA Questions Cardio Safety

WASHINGTON - Nearly two years after Merck withdrew its New Drug Application (NDA) to the FDA for the arthritis drug Arcoxia (etoricoxib) due to concerns over cardiovascular problems, the drug company recently re-submitted the application for marketing approval in the United States.

The manufacturer's Dec. 30, 2003, application for Arcoxia seeks approval to market the drug as a painkiller and a treatment for the symptoms of arthritis, chronic lower back pain, acute pain and ankylosing spondylitis, an inflammation of the spine. The drug is already sold in 38 countries in Europe, Latin America and Asia. Merck withdrew its initial NDA …