Mallinckrodt Gets FDA Approval of sNDA for Acthar Gel Injector

March 1, 2024, 1:57 PM UTC

Mallinckrodt said the FDA has approved its supplemental New Drug Application for the Acthar Gel Single-Dose Pre-filled SelfJect Injector

  • Acthar delivery device for chronic and acute inflammatory and autoimmune conditions
  • Expected to launch in US in 2h 2024

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Allegra Fradkin in New York at afradkin@bloomberg.net

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Sunil Kesur at skesur@bloomberg.net

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