Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Aug 11, 2009

FDA Clears Sandoz’ Generic Competitor to Astellas Transplant Drug

  • 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.


Related content

Be sure to take the GEN Poll

Drug Price Hikes

Novum Pharma recently raised the price of an acne cream by over 3,900% in less than a year-and-a-half and Mylan increased price of EpiPen from $100 to $608 . Do you think pharmaceutical companies need to be subjected to price controls?

More »