FDAsafety guidance83% confidence
FDA AP — ALECENSA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
Application NDA208434. Sponsor: HOFFMANN-LA ROCHE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ALECTINIB HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · Parkinson's Disease
- Sub-indication
- General
Related signal: Hoffmann-La Roche's Prasinezumab Trial Targets Early-Stage Parkinson's Disease