FDAsafety guidance77% confidence
FDA AP — BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Dr. Reddy's Labs; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA075351. Sponsor: NOVITIUM PHARMA. Submission status: AP. Submission type: SUPPL. Active ingredients: ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE.
Supporting Context
- Therapeutic area
- Diabetes · DPP-4 Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts ANDA for Sitagliptin Phosphate by Dr. Reddy's Labs