FDAsafety guidance77% confidence
FDA AP — LAMOTRIGINE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219677. Sponsor: TARO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LAMOTRIGINE.
Supporting Context
- Therapeutic area
- Oncology · Immunotherapy
- Sub-indication
- General
Related signal: FDA Grants Priority Review for Tecentriq Hybreza Supplement Application