FDAapproval72% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Lupin.
Regulatory Analysis
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.
Supporting Context
- Therapeutic area
- Oncology · Immunomodulator
- Sub-indication
- General
Related signal: Lupin's Lenalidomide ANDA214398 Receives Abbreviated Approval