FDAsafety guidance72% confidence
FDA AP — VYVANSE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Takeda.
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 · Sleep Disorders
- Sub-indication
- General
Related signal: Takeda's TAK-360 Trial for Narcolepsy Type 1 Underway