FDAsafety guidance66% confidence
FDA AP — COSOPT PF (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as THEA PHARMA; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA202667. Sponsor: THEA PHARMA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE.
Supporting Context
- Therapeutic area
- Ophthalmology · Glaucoma
- Sub-indication
- Ophthalmology
Related signal: FDA Accepts Application for COSOPT PF Supplement by THEA PHARMA