Exparel

NDA 22496, held by Pacira Pharms Inc. Bupivacaine.

As of Nov 15, 2026, NDA 22496 (Exparel), held by Pacira Pharms Inc, was first approved by FDA on Oct 28, 2011, with 22 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2011
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EXPAREL is indicated to produce postsurgical: Local analgesia via infiltration in patients aged 6 years and older Regional analgesia via an interscalene brachial plexus nerve block in adults Regional analgesia via a sciatic nerve block in the popliteal fossa in adults Regional analgesia via an adductor canal block in adults

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Nov 9, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 22, 2021	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 6, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label
Oct 28, 2011	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Exparel133MG/10ML (13.3MG/ML) · injectable, liposomal;injection	Bupivacaine	RxReference drug
Exparel266MG/20ML (13.3MG/ML) · injectable, liposomal;injection	Bupivacaine	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 51Labeling · Standard review	Approved	Label Letter
Nov 9, 2023	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 2, 2021	Supplement 37Manufacturing	Approved	Review
Mar 22, 2021	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 6, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 30Labeling · Standard review	Approved	Letter Label
Apr 6, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label
Mar 8, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Jun 10, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 15, 2016	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 5, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 14, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 8, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 11, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 27, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
May 27, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 15, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 5, 2014	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 13, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 28, 2011	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22496
Drugs@FDA: Overview at FDA
Company: Pacira Pharmaceuticals, Inc.

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