FDAapproval84% confidence
CDER proposes to withdraw approval of TAVNEOS
Source: FDA
Why This Matters
Why this matters: sets a approval 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
Supporting Context
- Therapeutic area
- Pain Management · NSAID
- Sub-indication
- Pain
Related signal: FDA Grants Approval for Aurobindo's Etodolac ANDA214872