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 (rare disease) as Annora 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
- Rare Diseases · Urea Cycle Disorders
- Sub-indication
- Rare Disease
Related signal: FDA Grants Approval for L-Glutamine ANDA219722 by Annora Pharma