Birch Triterpenes

Treats wounds associated with dystrophic and junctional epidermolysis bullosa (EB). Sold as Filsuvez. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Birch Triterpenes (sold as Filsuvez), first approved Dec 18, 2023, with 0 new uses approved and 1 published complete response letter.

First approved: Dec 18, 2023
Applications: 1
New uses approved: 0
Complete response letters: 1
Orphan exclusivity until: Dec 18, 2030

Who Was in the Trials

223 participants in the largest population FDA reports for the Dec 18, 2023 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 40%
65 and older: Not reported
White: 83%
Black: 1%
Asian: 5%
Hispanic or Latino: 35%

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of epidermolysis bullosaChiesi Farmaceutici S.p.A. · designated Aug 7, 2014 · approved Dec 18, 2023 · exclusive to Dec 18, 2030

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 18, 2023	FilsuvezNDA 215064 · New molecular entity	Chiesi	0	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Feb 26, 2022	Filsuvez (birch triterpenes)Clinical, Julie G Beitz	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA