FDAsafety guidance72% confidence
FDA AP — NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as opioid treatment pharma companies.
Regulatory Analysis
Application ANDA075523. Sponsor: SUN PHARM INDS LTD. Submission status: AP. Submission type: SUPPL. Active ingredients: NALOXONE HYDROCHLORIDE, PENTAZOCINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Addiction · Opioids
- Sub-indication
- Pain
Related signal: University of Missouri-Columbia Launches Naloxone Training Initiative to Combat Opioid Overdoses