Pfizer talking with FDA about Celebrex Bextra's return to market is still unclear, CEO says

Pfizer talking with FDA about Celebrex Bextra's return to market is still unclear, CEO says
By Elana Schor, Medill News Service
Last Update: 5:33 PM ET May 17, 2005

WASHINGTON (MarketWatch) -- Pfizer is waiting to finish negotiations with the Food and Drug Administration over the labeling of its anti-inflammatory drug Celebrex before pushing for the FDA to return Bextra to the market, CEO Hank McKinnell said Tuesday.

The FDA asked Pfizer (PFE: news, chart, profile) in April to pull Bextra after studies revealed potential for a serious skin reaction in some patients taking the painkiller. Bextra also was linked to cardiovascular side effects similar to those caused by two fellow COX-2 inhibitors: Vioxx, recalled by Merck in 2004, and Celebrex, which was required by the FDA to have a strong black box warning on its label....