collagenase clostridium histolyticum

FDA Drug Profile — XIAFLEX

Drug Details

Generic Name
collagenase clostridium histolyticum
Brand Names
XIAFLEX
Application Number
BLA125338
Sponsor
Jubilant HollisterStier LLC
NDC Codes
2
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, KIT
Routes
N/A
Active Ingredients
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Indications and Usage

1 INDICATIONS AND USAGE XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX is a combination of bacterial collagenases indicated for: The treatment of adult patients with Dupuytren’s contracture with a palpable cord ( 1 ) The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy ( 1 )