ANACAULASE-BCDB

FDA Drug Profile — NEXOBRID

Drug Details

Generic Name
ANACAULASE-BCDB
Brand Names
NEXOBRID
Application Number
BLA761192
Sponsor
Vericel Corporation
NDC Codes
3
Dosage Forms
KIT
Routes
TOPICAL
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns. Limitations of Use The safety and effectiveness of NEXOBRID have not been established for treatment of: Chemical or electrical burns Burns on the face, perineum, or genitalia Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease Circumferential burns Burns in patients with significant cardiopulmonary disease, including inhalation injury NEXOBRID is not recommended for: Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance. Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal. NEXOBRID contains proteolytic enzymes and is indicated for eschar removal in adults and pediatric patients with deep partial thickness and/or full thickness thermal burns ( 1 ). Limitations of Use The safety and effectiveness of NEXOBRID have not been established for treatment of: Chemical or electrical burns ( 1 ). Burns on the face, perineum, or genitalia ( 1 ). Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease ( 1 ). Circumferential burns ( 1 ). Burns in patients with significant cardiopulmonary disease, including inhalation injury ( 1 ). NEXOBRID is not recommended for: Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance ( 1 ) Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal ( 1 ).