BMS Manati Closeout Clears Path to Nulojix Approval

In a recent closeout letter, the FDA told Bristol-Myers Squibb (BMS) that the corrective actions BMS has taken at its Manati, Puerto Rico, facility “sufficiently addressed” concerns raised in an August 2010 warning letter, paving the way for the June 15 approval of BMS’ kidney transplant drug Nulojix.
Drug GMP Report