US prasugrel approval includes postmarketing study requirement on bleeding
20 July 2009
Sue Sutter
The US
FDA has required
Lilly/
Daiichi Sankyo to study whether platelet inhibition induced by Effient (prasugrel) can be reversed to stem bleeding. The postmarketing study requirement was contained in the agency's July 10th approval letter for the antiplatelet agent.
The sponsors have also agreed...
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