Tuesday, November 2, 2010

Suspension of licence to Manufacture/Sale/Distribution of Rosiglitazone

Drugs Controller General of India has requested All State Drug Controllers to suspend the Manufacture/Sale/Distribution of Rosiglitazone and rosiglitazone FDCs following the recommendation from an expert committee that was constituted to examine the safety issue of Rosiglitazone.

European Medicine Agency (EMEA) and U.S. FDA recently suspended the marketing authorisation of rosiglitazone and rosiglitazone FDCs due to the cardiovascular events and adverse effects on lipid profile.