Dr. Reddy's Laboratories (NYSE:RDY) today announced that it has launched tacrolimus capsules, (0.5mg, 1mg, 5mg), a bioequivalent generic version of Prograf® Capsules, in the US market on May 20, 2010. The United States Food & Drug Administration (USFDA) granted an approval of Dr. Reddy's ANDA for tacrolimus capsules on May 13, 2010.
Tacrolimus is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. Dosing should be titrated based on clinical assessments of rejection and tolerability. Dr. Reddy's product is available in bottles of 100 count capsules.
The Prograf® brand and the tacrolimus generics had combined sales of approximately $955 million in the United States, based on IMS sales data for the 12 months ending March 31, 2010.