FDAapproval84% confidence
Withdrawn | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (pain) as Dr. Reddy's Labs; 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includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.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
- Addiction · Opioid Dependence
- Sub-indication
- Pain
Related signal: FDA Approval Update for Buprenorphine and Naloxone from Dr. Reddy's Labs