FDAsafety guidance66% confidence
FDA AP — ACETAMINOPHEN 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 Incyte; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA040419. Sponsor: SPECGX LLC. Submission status: AP. Submission type: SUPPL. Active ingredients: ACETAMINOPHEN, CODEINE PHOSPHATE.
Supporting Context
- Therapeutic area
- Dermatology · JAK Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement for OPZELURA (Ruxolitinib Phosphate) by Incyte