FDAsafety guidance66% confidence
FDA AP — CALCIPOTRIENE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Glenmark; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA205772. Sponsor: GLENMARK SPECLT. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CALCIPOTRIENE.
Supporting Context
- Therapeutic area
- Dermatology · Psoriasis
- Sub-indication
- General
Related signal: FDA Acceptance of Calcipotriene Supplement by Glenmark