FDAsafety guidance66% confidence
Rare Disease Drug Approvals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Aurobindo Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
This page describes recent rare disease drug approvals that received CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals.
Supporting Context
- Therapeutic area
- Pain Management · NSAID
- Sub-indication
- Pain
Related signal: FDA Grants Approval for Aurobindo's Etodolac ANDA214872