TheraRadar
Data updated: May 26, 2026

KLARON (sulfacetamide sodium)

Dermatology Approved 1996-12-23

KLARON is indicated for the treatment of Acne Vulgaris.

Source: FDA Label • BAUSCH
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1996-12-23
Routes
TOPICAL
Dosage Forms
LOTION

Companies

Active Ingredient: SULFACETAMIDE SODIUM

KLARON Approval History

1997
1998
1999
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2001
2002
2003
2004
2005
2006
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2008
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2010
2011
2012
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2014
2015
2016
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2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 1996 to 2016
Feb 2016 SUPPL
Mfg · Manufacturing (CMC)
Oct 2015 SUPPL
Mfg · Manufacturing (CMC)
Dec 2014 SUPPL
Mfg · Manufacturing (CMC)

What KLARON Treats

1 indications

KLARON is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acne Vulgaris
Source: FDA Label

KLARON Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KLARON FDA Label Details

Indications & Usage

FDA Label (PDF)

KLARON is indicated for the treatment of Acne Vulgaris.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.