Mepron

Prevents Pneumocystis jirovecii pneumonia (PCP). NDA 20500, held by Glaxosmithkline LLC. Atovaquone.

As of Nov 13, 2026, NDA 20500 (Mepron), held by Glaxosmithkline LLC, was first approved by FDA on Feb 8, 1995, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 8, 1995
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MEPRON oral suspension is a quinone antimicrobial drug indicated for:

Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Limitations of Use:
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with MEPRON has not been studied.
The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jan 5, 1999	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Feb 8, 1995	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mepron750MG/5ML · suspension;oral	Atovaquone	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Mar 20, 2026	Supplement 20Labeling · Standard review	Approved	Label Letter
Jul 18, 2019	Supplement 19Labeling · Standard review	Approved	Label Letter
Feb 22, 2019	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 15, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 4, 2015	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 1, 2013	Supplement 14Labeling · Standard review	Approved	Label Letter
May 7, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 5, 1999	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Sep 14, 1998	Supplement 4Manufacturing · Priority review	Approved	None posted
Aug 12, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
May 2, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Apr 28, 1995	Supplement 1Manufacturing · Priority review	Approved	None posted
Feb 8, 1995	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20500
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