FDAsafety guidance66% confidence
FDA AP — DALFAMPRIDINE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for RISING; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA206863. Sponsor: ACCORD HLTHCARE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DALFAMPRIDINE.
Supporting Context
- Therapeutic area
- Oncology · Supportive Care
- Sub-indication
- General
Related signal: FDA Grants AP Status for MESNA ANDA203364 Submission by RISING