FDAsafety guidance77% confidence
FDA AP — BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Rextovy; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA205806. Sponsor: DR REDDYS LABS SA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · Opioid Overdose
- Sub-indication
- Pain
Related signal: FDA Approves OTC Naloxone Nasal Spray Rextovy for Opioid Overdose