Prescription medicine
Givinostat Brand names: Duvyzat
Givinostat (Duvyzat) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the givinostat FDA label on DailyMed (effective November 21, 2024); the NDA 217865 record on Drugs@FDA; every givinostat label on DailyMed.
Highlights of the record
FDA label of November 21, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
Forms and strengths
- 8.86 mg/ml
Suspension.
On the market
- Earliest approval on file
- March 21, 2024 Duvyzat, Italfarmaco Spa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 3, 2040 Duvyzat oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 560 through July 30, 2026
What is givinostat used for?
From the label: indications and usageDUVYZAT 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.
FDA pharmacologic class: Histone Deacetylase Inhibitor.
Source: FDA drug label (DUVYZAT), Italfarmaco SPA, effective November 21, 2024 (SPL set 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6), via openFDA; the full label on DailyMed
What does the patient leaflet for givinostat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DUVYZAT?DUVYZAT can cause serious side effects including: Low platelet counts in your blood (thrombocytopenia). Platelets are important for blood clotting, and a decrease in their numbers can lead to an increased risk of bleeding or bruising. Your healthcare provider will check your blood count before you start DUVYZAT and regularly during treatment for any signs of thrombocytopenia. Call your healthcare provider right away if you notice any unusual bleeding or small red or purple spots on the skin called petechiae. Your healthcare provider may change your dose of DUVYZAT if your blood platelet counts continue to be low or may stop your treatment with DUVYZAT. Increased levels of fat (triglycerides) in your blood. You may not have any symptoms, so your healthcare provider will do blood tests before you start DUVYZAT and regularly during treatment to check your triglyceride levels. Your healthcare provider may change your dose of DUVYZAT if your triglyceride levels continue to be high or may stop your treatment with DUVYZAT. Frequent watery loose stools (diarrhea) and vomiting. DUVYZAT can cause vomiting and moderate to severe diarrhea. If diarrhea occurs, you should keep track of the frequency and severity of your diarrhea symptoms, drink plenty of fluids, and contact your healthcare provider. Your healthcare provider may change your dose of DUVYZAT if the diarrhea cannot be managed or does not go away. Your healthcare provider may also stop your treatment with DUVYZAT.
Source: FDA drug label (DUVYZAT), Italfarmaco SPA, effective November 21, 2024 (SPL set 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6), via openFDA; the full label on DailyMed
Is there a generic for givinostat (Duvyzat)?
No generic givinostat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Duvyzat oral suspension: the compound patent runs to May 3, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for givinostat?
The FDA Adverse Event Reporting System holds 560 reports that list givinostat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other histone deacetylase inhibitors
- the pharmacologic class, with prices and generics
- Givinostat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other