Source: FDA, National Drug Code (US) Revision Year: 2024
DUVYZAT (givinostat) oral suspension contains givinostat hydrochloride monohydrate, a histone deacetylase inhibitor. Givinostat hydrochloride monohydrate is designated chemically as: [6-(diethylaminomethyl)naphthalen-2-yl]methyl[4(hydroxycarbamoyl) phenyl] carbamate hydrochloride monohydrate. The molecular formula is C24H27N3O4•HCl•H2O and the molecular weight is 475.97 g/mol. Its structural formula is:
Givinostat hydrochloride monohydrate is a white to off-white, non-hygroscopic, crystalline powder that is very slightly to slightly soluble in aqueous media and slightly soluble in ethanol.
DUVYZAT contains givinostat 8.86 mg/mL (equivalent to givinostat hydrochloride monohydrate 10 mg/mL) and the following inactive ingredients: cream flavor, glycerin, non-crystallizing sorbitol solution, peach flavor, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, tartaric acid, and tragacanth.
| Dosage Forms and Strengths |
|---|
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Oral suspension: 8.86 mg/mL givinostat as a white to off-white or faintly pink, peachcream flavored suspension. |
| How Supplied |
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DUVYZAT (givinostat) oral suspension is a white to off-white or faintly pink, peach-cream flavored suspension. It is supplied in an amber polyethylene terephthalate bottle closed with a high-density polyethylene child-resistant, screw cap with low-density polyethylene syringe adapter, containing 140 mL of oral suspension (NDC 11797-110-01). Each mL contains 8.86 mg of givinostat. DUVYZAT is supplied in a carton, NDC 11797-110-02, containing:
The Medication Guide is available at www.duvyzat.com/medication-guide. Manufactured by: Italfarmaco S.A., Madrid, Spain Distributed by: ITF Therapeutics, LLC, Concord, MA 01742 |
| Drug | Countries | |
|---|---|---|
| DUVYZAT | United States |
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