FDAsafety guidance66% confidence
FDA AP — BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Novitium Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA074951. Sponsor: STEVENS J. Submission status: AP. Submission type: SUPPL. Active ingredients: ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE.
Supporting Context
- Therapeutic area
- Neurology · Pain Management
- Sub-indication
- Pain
Related signal: Novitium Pharma's Butalbital Combination Receives FDA Submission Approval