Prescription medicine
Prademagene zamikeracel Brand names: Zevaskyn
Prademagene zamikeracel (Zevaskyn) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the prademagene zamikeracel FDA label on DailyMed (effective March 19, 2026); every prademagene zamikeracel label on DailyMed.
Highlights of the record
FDA label of March 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Forms and strengths
Cellular sheet.
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
What is prademagene zamikeracel used for?
From the label: indications and usageZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Source: FDA drug label (ZEVASKYN), Abeona Therapeutics Inc., effective March 19, 2026 (SPL set f8782480-8782-4748-9764-b9ed60979d47), via openFDA; the full label on DailyMed
Is there a generic for prademagene zamikeracel (Zevaskyn)?
No generic prademagene zamikeracel is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the prademagene zamikeracel label say about other medicines?
The prademagene zamikeracel 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 |
|---|---|---|
| Amikacin | warnings and precautions | WARNINGS AND PRECAUTIONS Hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. ( 5.1 ) Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. … |
| Vancomycin | warnings and precautions | WARNINGS AND PRECAUTIONS Hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. ( 5.1 ) Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. … |
Source: FDA drug label (ZEVASKYN), Abeona Therapeutics Inc., effective March 19, 2026 (SPL set f8782480-8782-4748-9764-b9ed60979d47), via openFDA; the full label on DailyMed
What next?
- Check an interaction
- what two or more labels say about each other