FDAsafety guidance66% confidence
FDA AP — SOTALOL HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for InvaGen Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA075725. Sponsor: RISING. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: SOTALOL HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Psychiatry · Antipsychotic
- Sub-indication
- General
Related signal: FDA Grants Approval for Lurasidone Hydrochloride ANDA208028