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FDA Medication Tracker

← All approvals · Other · 2024

Sofdra (sofpironium)

The FDA approved Sofdra (sofpironium) on June 18, 2024 to treat primary axillary hyperhidrosis.
Brand name
Sofdra
Generic name
sofpironium
FDA approval date
June 18, 2024
Approved use (FDA wording)
To treat primary axillary hyperhidrosis
Company
Botanix Sb
Application
NDA217347
Dosage form / route
GEL, METERED · TOPICAL
Boxed warning on label
Not listed
Category on this site
Other

Indications and usage, from the FDA label

SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.