Prescription medicine
Vorinostat Brand names: Zolinza
Vorinostat (Zolinza) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vorinostat FDA label on DailyMed (effective November 12, 2024, Merck Sharp & Dohme LLC); the NDA 21991 record on Drugs@FDA; every vorinostat label on DailyMed.
Highlights of the record
FDA label of November 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
Forms and strengths
- 100 mg
Capsule.
On the market
- Earliest approval on file
- October 6, 2006 Zolinza, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 18, 2028 Zolinza capsules; 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
- 2,146 through July 30, 2026
What is vorinostat used for?
From the label: indications and usageZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
FDA pharmacologic class: Histone Deacetylase Inhibitor.
Source: FDA drug label (ZOLINZA), Merck Sharp & Dohme LLC, effective November 12, 2024 (SPL set cd86ee78-2781-468b-930c-3c4677bcc092), via openFDA; the full label on DailyMed
Is there a generic for vorinostat (Zolinza)?
No generic vorinostat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Zolinza capsules: the compound patent runs to March 11, 2027, and the last listed entry to March 18, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vorinostat label say about other medicines?
The vorinostat label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). |
| Valproic acid | drug interactions | Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). |
Source: FDA drug label (ZOLINZA), Merck Sharp & Dohme LLC, effective November 12, 2024 (SPL set cd86ee78-2781-468b-930c-3c4677bcc092), via openFDA; the full label on DailyMed
What do FAERS reports show for vorinostat?
The FDA Adverse Event Reporting System holds 2,146 reports that list vorinostat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 420 are coded as a death and 995 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
- Vorinostat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other