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Withdrawn | Cancer Accelerated Approvals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includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.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 · Supportive Care
- Sub-indication
- General
Related signal: FDA Grants Approval for Leucovorin Calcium ANDA072734 by Hikma