The FDA blocks an injectable COX-2

Filed in archive News on September 21, 2005

Cautious - No surprise that the FDA rejected Pfizer's application for an injectable COX-2 medication:

The FDA issued for undisclosed reasons a "non-approvable letter" for Pfizer's parecoxib sodium, which is marketed in other parts of the world, including the european union, as Dynastat.

In a press release Tuesday, the drug giant said it disagrees with the FDA's conclusions and plans to meet with the agency about the rejection.

New York-based Pfizer argues that Dynastat, as the only injectable Cox-2 inhibitor, reduces the need for opioids to control pain after surgery.