FDAmanufacturing / CMC66% confidence
Other | Cancer Accelerated Approvals
Source: FDA
Why This Matters
Why this matters: sets a manufacturing / CMC precedent in the same sub-indication (cardiology) as RK Pharma; 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 granted for supportive care products and changes to dosing or formulation.
Supporting Context
- Therapeutic area
- Pulmonology · PAH
- Sub-indication
- Hypertension
Related signal: FDA Grants Approval for Selexipag Application ANDA214055