India DCGI Warning Seen Hurting Sales Of Avandia
This article was originally published in PharmAsia News
Executive Summary
At least three of India's generics makers can expect reduced sales of one of their drugs in the wake of a warning by their country's regulator about rosiglitazone. The drug is the API of GlaxoSmithKline's Avandia for keeping blood sugar levels low in diabetes patients. The GSK drug and generics made by India's Sun Pharmaceuticals, Dr. Reddy's Laboratories, Torrent Pharmaceuticals and 30 other companies contribute to sales to as many as 10 million of the nation's 41 million diabetics. The Drugs Controller General of India ordered the makers of the drug to include a warning of risks to diabetics who also have heart problems. The drug has a competitor, ploglitazone, already made by several other Indian drug makers, so physicians already have begun switching their patients. (Click here for more
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.