FDAsafety guidance77% confidence
FDA AP — LURASIDONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Torrent Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA208002. Sponsor: AMNEAL PHARMS CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LURASIDONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Psychiatry · Antipsychotic
- Sub-indication
- General
Related signal: Torrent's Lurasidone Hydrochloride ANDA Receives AP Status from FDA
Source
FDA document
View source