FDA Denies U.S. Approval for Merck's Cox-2 Arcoxia




ROCKVILLE, Md. - The FDA has rejected Merck & Co. Inc.'s request to market its selective Cox-2 inhibitor Arcoxia (etoricoxib) in the United States for the treatment of osteoarthritis, informing the drug manufacturer that the painkiller cannot be approved without additional supportive data.

Merck announced on April 27 that the FDA issued a non-approvable letter in response to the company's New Drug Application for Arcoxia, indicating that "Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval."

Arcoxia has been under review by the FDA since …






UPCOMING CONFERENCES




HarrisMartin’s Artificial Stone Silicosis Epidemic Litigation Conference

April 08, 2025 - Long Beach, CA
The Westin Long Beach

MORE DETAILS



HarrisMartin's Mass Tort Settlements Conference - Sponsored by Milestone

June 25, 2025 - Buffalo, NY
The Westin Buffalo

MORE DETAILS