India Orders Post-Marketing Data For Pfizer’s Champix
This article was originally published in PharmAsia News
Executive Summary
India's drug regulator has instructed U.S. drug maker Pfizer's Indian subsidiary to submit post-marketing data on the impact of its Champix (varenicline) drug to help smokers quit. Although Indian physicians have not reported seeing problems with use of the psychotropic drug, Pfizer was instructed to complete its post-marketing study by May of next year, followed by regular updates. A Pfizer Ltd. official said the study already is underway with 300 patients at 21 sites. India's post-marketing surveillance regulations usually are followed only if the government specifically orders them. (Click here for more