FDAsafety guidance66% confidence
FDA AP — MACITENTAN (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Teva; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA211000. Sponsor: AMNEAL. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: MACITENTAN.
Supporting Context
- Therapeutic area
- Cardiology · Pulmonary Arterial Hypertension
- Sub-indication
- Hypertension
Related signal: FDA Grants Approval for Macitentan ANDA211187 by Teva Pharmaceuticals