Bysanti

Treats schizophrenia. NDA 220358, held by Vanda Pharms Inc. Milsaperidone.

As of Nov 13, 2026, NDA 220358 (Bysanti), held by Vanda Pharms Inc, was first approved by FDA on Feb 20, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Feb 20, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 )

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Feb 20, 2026	Original applicationNew molecular entity · Standard review	Approved	Review Review Label Letter

Products

7 strengths and forms


Bysanti1MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti2MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti4MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti6MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti8MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti10MG · tablet;oral	Milsaperidone	RxReference drug
Bysanti12MG · tablet;oral	Milsaperidone	RxReference drug

Identifiers

Application: NDA 220358
Drugs@FDA: Overview at FDA
Company: Vanda Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters