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Nulojix Approval History

  • FDA approved: Yes (First approved June 15th, 2011)
  • Brand name: Nulojix
  • Generic name: belatacept
  • Dosage form: Injection
  • Company: Bristol-Myers Squibb Company
  • Treatment for: Organ Transplant, Rejection Prophylaxis

Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Development History and FDA Approval Process for Nulojix

Jun 16, 2011Approval FDA Approves Nulojix for Kidney Transplant Patients
May  3, 2010Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept
Mar  2, 2010FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients
Sep  3, 2009Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application

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