FDAsafety guidance66% confidence
FDA AP — SODIUM THIOSULFATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Lupin; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA203923. Sponsor: HOPE PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: SODIUM THIOSULFATE.
Supporting Context
- Therapeutic area
- Electrolyte Imbalance · Injectable
- Sub-indication
- General
Related signal: FDA Grants Approval for Lupin's Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride