FDAsafety guidance77% confidence
FDA AP — BRIMONIDINE TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Alembic Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA078480. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BRIMONIDINE TARTRATE.
Supporting Context
- Therapeutic area
- Ophthalmology · Glaucoma
- Sub-indication
- Ophthalmology
Related signal: Alembic's ANDA215230 for Brimonidine Tartrate and Timolol Maleate Receives AP Status