FDA hands Pfizer a non-approvable letter for injectable Cox-2

Pfizer announced that the FDA has rejected its injectable Cox-2 inhibitor--parecoxib sodium--for acute pain. Company officials immediately said that they disagreed with the FDA's decision and would meet with the agency to try and resolve its concerns. Pfizer noted that parecoxib sodium is widely available around the world as Dynastat, which has been reviewed and kept on the market since the revelations about Cox-2s first hit. Pfizer has been hit hard by the link between Cox-2s and an elevated risk of cardiovascular disease. The company still markets Celebrex--though sales have shrunk--and took Bextra off the market at the FDA's request.

- read this AP story for more