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FDA Medication Tracker

← All approvals · Rare & genetic · 2024

Duvyzat (givinostat)

The FDA approved Duvyzat (givinostat) on March 21, 2024 to treat Duchenne muscular dystrophy in individuals aged 6 years and older.
Brand name
Duvyzat
Generic name
givinostat
FDA approval date
March 21, 2024
Approved use (FDA wording)
To treat Duchenne muscular dystrophy in individuals aged 6 years and older
Company
Italfarmaco Spa
Application
NDA217865
Dosage form / route
SUSPENSION · ORAL
Drug class (EPC)
Histone Deacetylase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 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.