FDAsafety guidance65% confidence
FDA AP — ONTRUZANT (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Amneal Pharmaceuticals.
Regulatory Analysis
Application BLA761100. Sponsor: SAMSUNG BIOEPIS CO LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TRASTUZUMAB-DTTB.
Supporting Context
- Therapeutic area
- Oncology · Chemotherapy
- Sub-indication
- General
Related signal: Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine