FDAsafety guidance66% confidence
FDA AP — NGENLA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for TARO Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761184. Sponsor: PFIZER IRELAND PHARMACEUTICALS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: SOMATROGON-GHLA.
Supporting Context
- Therapeutic area
- Neurology · Anticonvulsant
- Sub-indication
- General
Related signal: TARO's ANDA219052 for PERAMPANEL Receives Approval Status