Nexobrid

For deep partial thickness (DPT) and/or full thickness (FT) thermal burns. BLA 761192, held by Mediwound, Ltd. Anacaulase-Bcdb.

As of Nov 14, 2026, BLA 761192 (Nexobrid), held by Mediwound, Ltd, was first approved by FDA on Dec 28, 2022, with 1 approved supplement and 1 published complete response letter.

First approved: Dec 28, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first


Aug 15, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 28, 2022	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jun 25, 2021	BLA 761192Product Quality, Facility Inspections, Clinical Site Inspections	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nexobrid8.8% · gel;topical	Anacaulase-Bcdb	Rx

Identifiers

Application: BLA 761192
Drugs@FDA: Overview at FDA
Company: MediWound

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