Accord’s 12-Year-Old Prograf Generic Has US Equivalence Rating Pulled

FDA Funded Studies Reveal Increased Risk Of Toxicity For Accord’s Transplant Drug

19 Sep 2023

Accord Healthcare has been told by the FDA that its generic version of Astellas Pharma’s Prograf capsules will no longer be automatically substituted for the brand following a series of post-approval studies dating back more than a decade.

FDASignBldg21Entrance_1200x675 — • Source: Shutterstock

The US Food and Drug Administration has removed the AB-rating indicating therapeutic equivalence with the reference product for Accord Healthcare’s generic Prograf (tacrolimus) 0.5mg, 1mg, and 5mg capsules, after a series of post-approval studies raised concerns of the risk for increased toxicity for patients taking Accord’s generic compared to Astellas Pharma’s branded immunosuppressant.

Tacrolimus capsule and injectable dosage forms were approved by the FDA under the Prograf name in 1994. The first generic version of tacrolimus capsules, from Sandoz, was approved in August...

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