FDAsafety guidance66% confidence
FDA AP — POKONZA (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as POKONZA; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA206814. Sponsor: GENUS LIFESCIENCES. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: POTASSIUM CHLORIDE.
Supporting Context
- Therapeutic area
- Cardiology · Electrolyte Replacement
- Sub-indication
- Hypertension
Related signal: FDA Accepts Supplement for POKONZA by Genus Lifesciences