Lamprene

Treats lepromatous leprosy, including dapsone-resistant lepromatous leprosy and…. NDA 19500, held by Novartis. Clofazimine.

As of Nov 13, 2026, NDA 19500 (Lamprene), held by Novartis, was first approved by FDA on Dec 15, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1986
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. 1.1 Lepromatous Leprosy LAMPRENE is indicated in combination with other anti-leprosy drugs for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 15, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms


Lamprene100MG · capsule;oral	Clofazimine	Discontinued
Lamprene50MG · capsule;oral	Clofazimine	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jul 27, 2026	Supplement 15Labeling · Standard review	Approved	Label
Jan 31, 2019	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
Jun 11, 2003	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 12, 2002	Supplement 9Manufacturing · Priority review	Approved	None posted
Jun 20, 2001	Supplement 8Manufacturing · Priority review	Approved	None posted
Jul 13, 2000	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 16, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Sep 12, 1995	Supplement 5Manufacturing · Priority review	Approved	None posted
Sep 5, 1995	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 20, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 30, 1989	Supplement 2Labeling	Approved	None posted
Sep 22, 1988	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 15, 1986	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 19500
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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