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FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

 
• By Brenda Sandburg

After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

Downgrade
FDA downgrades the therapeutic equivalence rating of Accord Healthcare's tacrolimus generic drug product • Source: Shutterstock

Accord Healthcare Ltd. is in the unusual situation of having the US Food and Drug Administration downgrade the therapeutic equivalence rating of its generic tacrolimus oral capsules after the agency changed its bioequivalence testing recommendations for tacrolimus products post-approval based on advice from an advisory committee.

Key Takeaways
  • Bioequivalence downgrades are a rare occurrence, but the process can be triggered for a variety of reasons, from the discovery of fraud at CROs to worrisome postmarketing reports.

The agency announced on 18 September that it is changing the therapeutic equivalence rating of Accord’s product, which was approved...

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