The FDA reduced its therapeutic equivalence rating in Accord Healthcare's tacrolimus oral capsules because of safety concerns, but the generic's approval remains, the agency said Sept. 19.
Tacrolimus is a generic for Astellas Pharma's Prograf and is indicated for preventing organ rejection in patients receiving kidney, liver or heart transplants. Accord's tacrolimus oral capsules might increase the risk for tacrolimus-associated toxicity, the FDA said, because data showed a peak blood level that was higher than the branded drug.
The solutions "may deliver drug to the body at a higher peak concentration compared to Prograf," but they do not deliver less drug than Prograf, the agency said.
The FDA changed the therapeutic equivalence rating for Accord's generic from AB to BX, which allows the drug to remain approved and prescribed but means it "is not recommended as automatically substitutable … for the brand-name drug," the FDA said.
The affected products are Accord's 0.5 milligram, 1 milligram and 5 milligram tacrolimus oral capsules. No other approved tacrolimus solutions are affected.
Becker's has reached out to Accord Healthcare for comment and will update the story if more information becomes available.