The Central Government has notified an immediate ban on the manufacturing and marketing of Valdecoxib formulations in the country. The ban is effective from July 25, 2005.
The companies still selling Valdecoxib in the market will have to withdraw its stocks now. Glenmark is one of the leading players in this segment.
The central notification was expected for some time now as the National Pharmacovigilance Advisory Committee (NPAC) had recommended the ban about three months ago. In the absence of any authentic data generated from within the country, the NPAC had taken serious note of the US FDA observations on the risk benefit profile of Valdecoxib. This is the second COX2 inhibitor after Rofecoxib, to be withdrawn from Indian market.
It should be noted that Ranbaxy Laboratories had voluntarily discontinued the marketing of Valdecoxib with immediate effect after it was known that US FDA asked Pfizer to suspend the sales of its arthritis drug, Bextra (Valdecoxib), due to unfavourable risk benefit ratio.