FDAsafety guidance66% confidence
FDA AP — NUCYNTA ER (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Collegium Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA200533. Sponsor: COLLEGIUM PHARM INC. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: TAPENTADOL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Accepts Supplement Application for NUCYNTA (Tapentadol Hydrochloride)