FDAsafety guidance66% confidence
FDA AP — VYVANSE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Takeda; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA208510. Sponsor: TAKEDA PHARMS USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LISDEXAMFETAMINE DIMESYLATE.
Supporting Context
- Therapeutic area
- Neurology · ADHD
- Sub-indication
- General
Related signal: FDA Accepts Supplement for Vyvanse (NDA 208510) from Takeda