FDAsafety guidance66% confidence
FDA TA — VILOXAZINE HYDROCHLORIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Epic Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA220326. Sponsor: APPCO PHARMA LLC. Submission status: TA. Submission type: ORIG. Review priority: STANDARD. Active ingredients: VILOXAZINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Cardiovascular · Beta-blocker
- Sub-indication
- General
Related signal: FDA Accepts Supplement for Labetalol Hydrochloride by Epic Pharma