Perseris Kit

NDA 210655, held by Indivior. Risperidone.

As of Nov 13, 2026, NDA 210655 (Perseris Kit), held by Indivior, was first approved by FDA on Jul 27, 2018, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 27, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Dec 15, 2022	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 27, 2018	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Products

2 strengths and forms


Perseris Kit90MG · for suspension, extended release;subcutaneous	Risperidone	DiscontinuedReference drug
Perseris Kit120MG · for suspension, extended release;subcutaneous	Risperidone	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 30, 2026	Supplement 15Manufacturing	Approved	None posted
Jan 24, 2025	Supplement 14Labeling · Standard review	Approved	Letter Label
Dec 15, 2022	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 29, 2022	Supplement 11Manufacturing · Standard review	Approved	Label
Feb 5, 2020	Supplement 4Labeling	Approved	Label Letter
Jul 27, 2018	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 210655
Drugs@FDA: Overview at FDA
Company: Indivior

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