Immunosuppressive drug

FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR®

Retrieved on: 
Friday, April 20, 2018
Medicine, Health, Clinical medicine, RTT, Food and Drug Administration, Pharmaceuticals policy, Prescription Drug User Fee Act, Vaccine, Immunosuppressive drug, Diarrhea, Immunosuppression

FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of January 7, 2019.

Key Points: 
  • FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of January 7, 2019.
  • Immunosuppressants, including ENVARSUS XR, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
  • Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with ENVARSUS XR.
  • Most common adverse reactions (incidence 10%) reported with ENVARSUS XR are: diarrhea and blood creatinine increased.