Astellas will push the agency for more rigorous bioequivalence testing of generic immuosuppressants.
Sandoz will launch the first generic version of Astellas’ transplant rejection drug, Prograf (tacrolimus), in the US. Prograf reportedly made $929 million in U.S. sales in the first four months of this year.
FDA approval of Sandoz’ generic immunosuppressant comes just 24 hours after Astellas confirmed that the agency had rejected its citizen petition, which requested the FDA to ask for bioequivalence studies of generic tacrolimus in transplant patients as well as in healthy volunteers.
Astellas says that it now plans to file a complaint for declaratory and injunctive relief in U.S. District Court in Washington, DC, challenging FDA’s decision to apply only standard bioequivalence testing for the approval of generic versions of drugs like tacrolimus. The company will also challenge FDA ‘s denial of the company’s request for labeling changes that would make it mandatory for transplant specialists to be notified whenever a substituted oral formulation of tacrolimus was prescribed to a transplant patient.
