SANDOZ: Lanza genérico de PROGRAF y ASTELLAS "suelta astillas" en la FDA...

Sandoz has introduced the first generic version of Astellas Pharma US’ immunosuppressant Prograf after the FDA rejected Astellas’ citizen petition requesting added bioequivalence studies for generic versions of the drug.



Astellas plans to file a complaint in the U.S. District Court for the District of Columbia challenging the agency’s decision to apply standard bioequivalence testing for the approval of generic immunosuppressant drugs, including versions of Prograf (tacrolimus), the company says in a statement.

The agency’s current standards for bioequivalence aren’t adequate to ensure the safety of transplant patients who are switched from one immunosuppressant drug to another, Astellas says. The FDA has posted a response to the petition on its website.
Drug Industry Daily