New Testing Prompts New Finding Of NDMA, Cancer Risk In Metformin Products
Executive Summary
The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks.
You may also be interested in...
Looming Launches Predicted To Offset Lupin Pressures
Lupin delivered a shaky Q3 as profit margins fell following complications with metformin and oseltamivir, but the firm appears confident that several impending high-value launches will set it back on the right track.
FDA Expedites ANDA Postapproval Manufacturing Changes
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.
US FDA Expediting ANDA Postapproval Manufacturing Changes Due To COVID-19 Impacts
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.