Now that the first license for a drug has been obtained in partnership with the program, work will begin to ensure other companies that make the product adopt the new licensed indication.

Now that the first license for a drug has been obtained in partnership with the program, work will begin to ensure other companies that make the product adopt the new licensed indication.

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.

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.