FDAsafety guidance66% confidence
FDA TA — ABANTA (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bristol Myers Squibb; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA221024. Sponsor: AZURITY. Submission status: TA. Submission type: ORIG. Review priority: STANDARD. Active ingredients: APIXABAN.
Supporting Context
- Therapeutic area
- Cardiovascular · Anticoagulant
- Sub-indication
- General
Related signal: FDA Submission Status Update for ABANTA (Apixaban) by AZURITY