FDA Reverses Stance On Bioequivalence Standards For Mesalamine
Executive Summary
FDA believes that comparative pharmacokinetic studies, instead of comparative clinical endpoint studies, are best for determining bioequivalence of extended- or delayed-release mesalamine products - a reversal of its previous position
You may also be interested in...
Sun Outstrips Viatris’ Pentasa Action Date With First ANDA Approval
Sun Pharma has scooped a first ANDA approval for a rival to Takeda’s mesalamine-containing brand Pentasa, with Viatris making clear recently that it was eyeing a first-time generic launch for the gastrointestinal drug.
FDA Bioequivalence Guidance Expands Crossover Designs For ANDA Studies
Guidance “will be especially useful” for planning studies to support postapproval ANDA changes, the agency notes.
Pediatric Bioequivalence Studies Are Unnecessary, FDA Says In Rejecting Nycomed Petition
Nycomed had sought additional approval requirements for generic versions of its atopic dermatitis lotion Cutivate.