Malarone, Malarone Pediatric

Prevents Plasmodium falciparum malaria, including in areas. NDA 21078, held by Glaxosmithkline. Atovaquone; Proguanil Hydrochloride.

As of Nov 14, 2026, NDA 21078 (Malarone, Malarone Pediatric), held by Glaxosmithkline, was first approved by FDA on Jul 14, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 14, 2000
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Atovaquone and Proguanil Hydrochloride tablets are an antimalarial indicated for:

prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
treatment of acute, uncomplicated P. falciparum malaria. 1.1 Prevention of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Dec 2, 2003	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 2, 2002	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 14, 2000	Original applicationNew combination · Priority review	Approved	Letter Review Label

Products

2 strengths and forms


Malarone250MG;100MG · tablet;oral	Atovaquone; Proguanil Hydrochloride	RxReference drug
Malarone Pediatric62.5MG;25MG · tablet;oral	Atovaquone; Proguanil Hydrochloride	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Jun 10, 2026	Supplement 26Labeling · Standard review	Approved	Label Letter
Mar 23, 2026	Supplement 25Labeling · Standard review	Approved	Label Letter
Feb 22, 2019	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 27, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 2, 2009	Supplement 17Labeling · Standard review	Approved	Letter
Dec 18, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
May 7, 2008	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 4, 2007	Supplement 12Labeling · Standard review	Approved	Letter
Feb 27, 2005	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 27, 2005	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 24, 2004	Supplement 7Labeling · Standard review	Approved	Label Letter
Sep 3, 2004	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 2, 2003	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 9, 2003	Supplement 5	Approved	Review
Aug 2, 2002	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
May 13, 2002	Supplement 4Manufacturing · Priority review	Approved	Review
Feb 28, 2002	Supplement 1Labeling · Standard review	Approved	Review Letter
Jul 14, 2000	Original applicationNew combination · Priority review	Approved	Letter Review Label

Identifiers

Application: NDA 21078
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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