Gralise

Manages postherpetic neuralgia. NDA 22544, held by Almatica. Gabapentin.

As of Nov 14, 2026, NDA 22544 (Gralise), held by Almatica, was first approved by FDA on Jan 28, 2011, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2011
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. GRALISE is indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (See Warnings and Precautions )

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 28, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

5 strengths and forms


Gralise300MG · tablet;oral	Gabapentin	RxReference drug
Gralise600MG · tablet;oral	Gabapentin	RxReference drug
Gralise450MG · tablet;oral	Gabapentin	RxReference drug
Gralise750MG · tablet;oral	Gabapentin	RxReference drug
Gralise900MG · tablet;oral	Gabapentin	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Apr 25, 2025	Supplement 31Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 18, 2023	Supplement 29Manufacturing	Approved	Letter Label
Sep 16, 2021	Supplement 27Manufacturing	Approved	Review Letter Label
Apr 2, 2020	Supplement 26Labeling · Standard review	Approved	Label Letter
Mar 6, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Jan 9, 2017	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 9, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 31, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 10, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 9, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 28, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 27, 2013	Supplement 12Manufacturing · Standard review	Approved	Label
Mar 25, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 13, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 30, 2012	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 8, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 31, 2012	Supplement 6Labeling · Standard review	Approved	Letter Label
Jun 28, 2011	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 28, 2011	Supplement 3REMS	Approved	Letter
Jan 28, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22544
Drugs@FDA: Overview at FDA
Company: Almatica Pharma

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