CDEK
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birch triterpenes

Trade name: Filsuvez

BotanicalapprovedOrphan Drug FDAFast Track FDA

Approved

Dec 18, 2023

Clinical trial activity

0 trials · 0 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0

Timeline

2010s

  1. Aug 7, 2014

    Orphan Drug Designation

2020s

  1. Dec 18, 2023

    Chiesi — Earliest FDA Approval

  2. Dec 18, 2023

    Chiesi — NDA Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedFast trackDec 18, 2023

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

First in class

Sources

Organizations

Marketing (1)

OrganizationOrg typeRelationshipDate
ChiesiFor profitNDADec 18, 2023