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