FDAsafety guidance66% confidence
FDA AP — STRATTERA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Eli Lilly; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA021411. Sponsor: LILLY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ATOMOXETINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Psychiatry · ADHD
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for Strattera by Lilly