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prademagene zamikeracel

FDA Drug Profile — ZEVASKYN

Drug Details

Generic Name
prademagene zamikeracel
Brand Names
ZEVASKYN
Application Number
BLA125807
Sponsor
Abeona Therapeutics Inc.
NDC Codes
1
Dosage Forms
CELLULAR SHEET
Routes
TOPICAL
Active Ingredients
PRADEMAGENE ZAMIKERACEL

Indications and Usage

1 INDICATIONS AND USAGE ZEVASKYN 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). ( 1 )