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FDA Grants $2.7 Million for Comparison Study of Prograf vs. Generics

The FDA has given $2.7 million to University of Cincinnati researchers to study whether generic versions of the transplant drug Prograf have the same efficacy as Astellas Pharma’s branded product. The prospective, blinded, six-way crossover clinical trial will compare Prograf (tacrolimus) to the two most disparate generics based on potency, purity and dissolution to determine whether the generics are bioequivalent to the innovator drug in stable transplant patients.
Washington Drug Letter