FDAsafety guidance84% confidence
FDA TA — ANDA219413
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Protega Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219413. Sponsor: TEVA PHARMACEUTICALS, INC.. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Accepts Supplement for RoxyBond by Protega Pharmaceuticals