FDAsafety guidance66% confidence
FDA AP — CONCERTA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Janssen Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA021121. Sponsor: JANSSEN PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: METHYLPHENIDATE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · ADHD
- Sub-indication
- General
Related signal: FDA Accepts Supplemental Application for Concerta by Janssen
Source
FDA document
View source