FDAsafety guidance77% confidence
FDA AP — DAPAGLIFLOZIN (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Jiangsu Hansoh Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA211468. Sponsor: AUROBINDO PHARMA. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: DAPAGLIFLOZIN.
Supporting Context
- Therapeutic area
- Diabetes · SGLT2 Inhibitor
- Sub-indication
- General
Related signal: FDA Submission for Dapagliflozin by Jiangsu Hansoh Pharma