Prescription medicine
Vamorolone Brand names: Agamree
Vamorolone (Agamree) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vamorolone FDA label on DailyMed (effective January 22, 2026, Catalyst Pharmaceuticals, Inc.); the NDA 215239 record on Drugs@FDA; every vamorolone label on DailyMed.
Highlights of the record
FDA label of January 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- October 26, 2023 Agamree, Catalyst Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 16, 2040 Agamree 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
- 1,610 through July 30, 2026
What is vamorolone used for?
From the label: indications and usageAGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Source: FDA drug label (AGAMREE), Catalyst Pharmaceuticals, Inc., effective January 22, 2026 (SPL set fb376f09-cf9c-42b5-b4dd-02d5bcd73211), via openFDA; the full label on DailyMed
Is there a generic for vamorolone (Agamree)?
No generic vamorolone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Agamree oral suspension: the compound patent runs to July 16, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 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 does the vamorolone label say about other medicines?
The vamorolone 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 |
|---|---|---|
| Itraconazole | drug interactions | Drugs on Vamorolone Co-administration of AGAMREE with itraconazole, a strong CYP3A4 inhibitor, increases vamorolone exposure [see Clinical Pharmacology ( 12.3 )]. |
| Levothyroxine | warnings and precautions | When concomitant administration of AGAMREE and levothyroxine is required, administration of AGAMREE should precede the initiation of levothyroxine therapy to reduce the risk of adrenal crisis. |
Source: FDA drug label (AGAMREE), Catalyst Pharmaceuticals, Inc., effective January 22, 2026 (SPL set fb376f09-cf9c-42b5-b4dd-02d5bcd73211), via openFDA; the full label on DailyMed
What do FAERS reports show for vamorolone?
The FDA Adverse Event Reporting System holds 1,610 reports that list vamorolone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 186 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?
- Vamorolone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other