Quick answers
- What is Milsaperidone used for?
- The FDA-approved label (Bysanti, Vanda Pharmaceuticals Inc., February 27, 2026) says: “BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults […]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults […]. BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1, 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1, 14.2 )” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Milsaperidone have a boxed warning?
- Yes. The FDA label for Bysanti has a boxed warning (“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Milsaperidone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Milsaperidone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Milsaperidone?
- 1 company lists prescription products of Milsaperidone in the FDA NDC Directory, including Vanda Pharmaceuticals Inc..
What Milsaperidone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults […]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults […]. BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1, 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1, 14.2 )
— FDA label: Bysanti, Vanda Pharmaceuticals Inc., effective February 27, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Bysanti |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Vanda Pharmaceuticals Inc.10 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA220358 BYSANTI | Vanda Pharms Inc | February 20, 2026 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Bysanti, Vanda Pharmaceuticals Inc., effective February 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →