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 …