COX-2 GI Labeling Changes Will Have Minimal Impact, Pharmacia Predicts
Executive Summary
COX-2 inhibitor class warnings of gastrointestinal toxicities are not likely to be removed from the label, Pharmacia Global Prescription Business President Carrie Cox told an April 25 analysts conference call.
You may also be interested in...
Merck Vioxx Sales Will Fall Short Of High Expectations, Firm Says
Merck's Vioxx sales are showing the impact of a slower penetration rate of COX-2 inhibitors into the analgesic market, the company said June 22.
Merck Vioxx Sales Will Fall Short Of High Expectations, Firm Says
Merck's Vioxx sales are showing the impact of a slower penetration rate of COX-2 inhibitors into the analgesic market, the company said June 22.
COX-2 inhibitor safety labels
FDA issues "approvable" letter April 6 for Merck's Vioxx (rofecoxib) for the inclusion of updated gastrointestinal safety data in labeling. Pharmacia/Pfizer's Celebrex (celecoxib) receives "approvable" letter April 12. FDA's Arthritis Advisory Committee recommended Feb. 7-8 that Vioxx and Celebrex could incorporate GI safety data in product labels (1"The Pink Sheet" Feb. 19, p. 11)