FDA Fast Track Designation Records – Belatacept (Nulojix), BLA 125288

Original Request: Documentation related to the 01/26/2005 Fast Track Designation of belatacept (Sponsor Bristol-Myers Squibb Company) for the prophylaxis/prevention of rejection in patients receiving a kidney transplant. Documents to include: (1) Fast Track Designation approval letter from FDA, (2) Sponsor application (initial and all amendments, as appropriate) requesting Fast Track Designation, and (3) Formal correspondence between Sponsor and FDA during review. Note that belatacept (Tradename Nulojix) was approved (BLA 125288) on 06/15/2011 for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.