FDAsafety guidance66% confidence
FDA AP — SYNALGOS-DC (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA011483. Sponsor: SUN PHARM INDUSTRIES. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: ASPIRIN, CAFFEINE, DIHYDROCODEINE BITARTRATE.
Supporting Context
- Therapeutic area
- Pain Management · Combination Analgesic
- Sub-indication
- Pain
Related signal: FDA Approves Supplemental NDA for SYNALGOS-DC by Sun Pharma