FDAsafety guidance66% confidence
FDA AP — REXTOVY (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Amphastar Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA208969. Sponsor: AMPHASTAR PHARMS INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: NALOXONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · Opioid Overdose
- Sub-indication
- Pain
Related signal: FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals