FDAsafety guidance83% confidence
FDA AP — IDVYNSO (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck.
Regulatory Analysis
Application NDA216964. Sponsor: MSD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DORAVIRINE, ISLATRAVIR.
Supporting Context
- Therapeutic area
- Infectious Disease · HIV
- Sub-indication
- General
Related signal: Merck Partners with ADAP to Enhance Access to IDVYNSO for HIV Treatment