FDA concern on Accord Healthcare Tacrolimus capsules

FDA has raised concerns about therapeutic equivalence of Tacrolimus capsules of Accord Healthcare to brand name drug Prograf (tacrolimus) oral capsules. Tacrolimus is indicated for the prevention of organ rejection in patients receiving kidney, liver, or heart transplants. FDA has changed Therapeutic equivalence (TE) rating for Accords Tacrolimus capsules from AB to BX, meaning data is insufficient to show the capsules show same therapeutic effect and safety profile as Prograf. Accord Healthcare Inc.’s tacrolimus oral capsules are still FDA-approved and can be prescribed, but are no longer recommended as automatically substitutable for Prograf (tacrolimus) oral capsules. The concern is about peak blood concentration of tacrolimus and risk of toxicity with Accord’s product. Accord’s Tacrolimus capsules were approved by FDA in 2011 (ANDA 091195) and is manufactured by Intas Pharmaceuticals, Ahmedabad, India.

FDA had updated the recommendations for design of bioequivalence studies for tacrolimus products in 2012, after qualifying tacrolimus products as narrow therapeutic index drugs. This led to concerns regarding substitutability of FDA-approved generic tacrolimus oral capsules that were approved prior to 2012. FDA funded multiple studies to investigate the concerns and based on the results concluded Accord’s tacrolimus oral capsules may deliver drug to the body at a higher maximum concentration compared to Prograf’s tacrolimus oral capsules.

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Questions and Answers Regarding Tacrolimus Oral Capsules (generic of Prograf) Made by Accord Healthcare Inc.