Lybalvi

NDA 213378, held by Alkermes Inc. Olanzapine; Samidorphan L-Malate.

As of Nov 13, 2026, NDA 213378 (Lybalvi), held by Alkermes Inc, was first approved by FDA on May 28, 2021, with 5 approved supplements and 0 published complete response letters.

First approved: May 28, 2021
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


May 28, 2021	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label
May 28, 2021	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Lybalvi5MG;EQ 10MG BASE · tablet;oral	Olanzapine; Samidorphan L-Malate	RxReference drug
Lybalvi10MG;EQ 10MG BASE · tablet;oral	Olanzapine; Samidorphan L-Malate	RxReference drug
Lybalvi15MG;EQ 10MG BASE · tablet;oral	Olanzapine; Samidorphan L-Malate	RxReference drug
Lybalvi20MG;EQ 10MG BASE · tablet;oral	Olanzapine; Samidorphan L-Malate	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Jan 30, 2026	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 28, 2025	Supplement 8Labeling · Standard review	Approved	Letter Label Medication Guide
Jan 22, 2025	Supplement 9Labeling · Standard review	Approved	Letter Label
Jan 30, 2024	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 25, 2023	Supplement 5Labeling · Standard review	Approved	Label Letter
May 28, 2021	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label
May 28, 2021	Original applicationNew molecular entity, new combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 213378
Drugs@FDA: Overview at FDA
Company: Alkermes

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