FDAsafety guidance54% confidence
FDA TA — VERICIGUAT (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Torrent Pharmaceuticals.
Regulatory Analysis
Application ANDA220221. Sponsor: TORRENT PHARMACEUTICALS LTD. Submission status: TA. Submission type: ORIG. Review priority: STANDARD. Active ingredients: VERICIGUAT.
Supporting Context
- Therapeutic area
- Cardiology · Heart Failure
- Sub-indication
- Hypertension
Related signal: Torrent Pharmaceuticals submits ANDA for Vericiguat