FDAsafety guidance66% confidence
FDA AP — LISDEXAMFETAMINE DIMESYLATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for ACCORD; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA202827. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LISDEXAMFETAMINE DIMESYLATE.
Supporting Context
- Therapeutic area
- Oncology · Hormonal Therapy
- Sub-indication
- General
Related signal: FDA Accepts Supplement for CAMCEVI ETM (Leuprolide Mesylate)