According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified Release formulation – an immunosupressant for the prophylaxis of organ rejections in patients who receive liver transplants. FK506 is a once daily formulation of the existing product Prograf (tacrolimus).
No FDA reasoning for the approval letter was stated by the company.
This is the second approvable letter that the company has received for this product for this indication, having gotten one in January 2007 13 months after filing the NDA in December 2005. After submitting a response in July 2007, the company received the second approvable letter April 30, 2008 and announced its receipt today.
The company also states in the release that it received an approvable letter for once-daily Prograf for use in kidney transplantation in January 2007 and again in March 2008 and got a not approvable letter for use in heart transplantation, also in January 2007.