FDAsafety guidance66% confidence
FDA AP — PIMOZIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Novitium Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219897. Sponsor: NOVITIUM PHARMA. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: PIMOZIDE.
Supporting Context
- Therapeutic area
- Neurology · Antipsychotic
- Sub-indication
- General
Related signal: FDA Grants Approval for Pimozide ANDA219897 by Novitium Pharma
Source
FDA document
View source