Friday, April 08, 2005
FDA Public Health Advisory FDA Announces Important Changes and Additional Warnings for COX-2 Selective�and Non-Selective Non-Steroidal Anti-Inflammato
"Today, the Food and Drug Administration (FDA) is announcing that it has asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide." [FDA Repost @ Alexanderlaw.com]