Original New Drug Application Approvals by US FDA (01- 15 October 2020)

19 Oct 2020
Original New Drug Application Approvals by US FDA (01- 15 October 2020)
New drug applications approved by US FDA as of 01 - 15 October 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

INMAZEB
  • Active Ingredient(s): Atoltivimab; odesivimab; maftivimab
  • Strength: 16.7 mg/mL
  • Dosage Form(s) / Route(s): Solution; injection
  • Company: Regeneron Pharmaceuticals
  • Approval Date: 14 October 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
  • Approved Label: 14 October 2020 (PDF)