Bysanti (milsaperidone)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- milsaperidone
- Company
- Vanda Pharms Inc
- Status
- Approved
- FDA approval
- Fri 20 Feb 2026
- Designations
- New molecular entity
- Application
- NDA220358
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Sat 21 Feb 2026🇺🇸 PDUFA datecompany-announced
Bysanti: PDUFA target action date (bipolar I disorder and schizophrenia)
Vanda Pharmaceuticals Inc. (VNDA); milsaperidone; NDA; status: set; "…Bysanti TM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026"; filed 2026-02-11 · source
Fri 20 Feb 2026🇺🇸 FDA approval
FDA approves Bysanti (milsaperidone), a new medicine
Vanda Pharms Inc; NDA220358; New molecular entity; tablet · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.