FDAsafety guidance66% confidence
FDA TA — NDA220613
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Annora Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA220613. Sponsor: HANDA ONCOLOGY, LLC. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Cardiology · Diuretic
- Sub-indication
- Hypertension
Related signal: FDA Grants AP Status for Spironolactone ANDA217761 by Annora Pharma