Intuniv

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 22037, held by Takeda Pharms USA. Guanfacine Hydrochloride.

As of Nov 14, 2026, NDA 22037 (Intuniv), held by Takeda Pharms USA, was first approved by FDA on Sep 2, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 2, 2009
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Mar 18, 2015	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 19, 2014	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric CDTL Review
Feb 20, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 25, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 2, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Products

4 strengths and forms


IntunivEQ 1MG BASE · tablet, extended release;oral	Guanfacine Hydrochloride	RxReference drug
IntunivEQ 2MG BASE · tablet, extended release;oral	Guanfacine Hydrochloride	RxReference drug
IntunivEQ 3MG BASE · tablet, extended release;oral	Guanfacine Hydrochloride	RxReference drug
IntunivEQ 4MG BASE · tablet, extended release;oral	Guanfacine Hydrochloride	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Dec 27, 2019	Supplement 19Labeling · Standard review	Approved	Label Letter
Apr 30, 2019	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 7, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 27, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 7, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 18, 2015	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 19, 2014	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric CDTL Review
Aug 23, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 20, 2013	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 8, 2011	Supplement 6Labeling	Approved	Letter Label
Feb 25, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 2, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22037
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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