Sofpironium Bromide

Treats primary axillary hyperhidrosis. Sold as Sofdra. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Sofpironium Bromide (sold as Sofdra), first approved Jun 18, 2024, with 0 new uses approved and 1 published complete response letter.

First approved: Jun 18, 2024
Applications: 1
New uses approved: 0
Complete response letters: 1
Medicare spending, 2025: $0K
First approved in Japan: Sep 25, 2020

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Sofdra	Part D	$0K	New	0

Approvals in Japan (PMDA)

First approved in Japan 45 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Ecclock, new ingredientA drug with a new active ingredient indicated for the treatment of primary axillary hyperhidrosis. · Kaken Pharmaceutical Co., Ltd. · Sep 25, 2020

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jun 18, 2024	SofdraNDA 217347 · New molecular entity	Botanix Sb	0	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Sep 22, 2023	Sofpironium bromideHuman Factors	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