FDAapproval95% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Hikma; the same agency is already in play for this signal, so precedent weight is higher.
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includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.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 · Chemotherapy Adjunct
- Sub-indication
- General
Related signal: Hikma's Leucovorin Calcium ANDA072735 Receives Abbreviated Approval