Prescription medicine
Vyjuvek
Vyjuvek is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vyjuvek FDA label on DailyMed (effective September 29, 2025); every vyjuvek label on DailyMed.
Highlights of the record
FDA label of September 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
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
- 129 through July 30, 2026
What is vyjuvek used for?
From the label: indications and usageVYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Source: FDA drug label (VYJUVEK), Krystal Biotech, Inc., effective September 29, 2025 (SPL set fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2), via openFDA; the full label on DailyMed
What does the patient leaflet for vyjuvek 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 VYJUVEK Gel?…The VYJUVEK® biological suspension must be mixed with the gel at the pharmacy prior to use. …VYJUVEK gel should be applied by a healthcare professional (HCP) or by a patient/caregiver either at a healthcare professional setting (e.g., clinical) or a home setting.
From the patient leaflet: What should I avoid while taking VYJUVEK Gel?…Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following VYJUVEK gel application. …Individuals should wear protective gloves when assisting with changing wound dressings and handling the disposal of the dressings.
From the patient leaflet: How should I store VYJUVEK Gel?…See the Instructions For Use for detailed instructions. …VYJUVEK gel syringes may remain at room temperature (20° to 25°C (68° to 77°F)) for up to 8 hours prior to application. Administration syringes can be kept in an appropriate insulated or temperature regulated secondary container for up to 48 hours at 2° to 8°C (35.6° to 46.4°F). …Follow expiration information provided by the pharmacy. If you have any questions, reach out to the pharmacy for additional information.
Source: FDA drug label (VYJUVEK), Krystal Biotech, Inc., effective September 29, 2025 (SPL set fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2), via openFDA; the full label on DailyMed
Is there a generic for vyjuvek?
No generic vyjuvek is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for vyjuvek?
The FDA Adverse Event Reporting System holds 129 reports that list vyjuvek among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 15 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Vyjuvek side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other