Ecallantide

FDA Drug Profile — Kalbitor

Drug Details

Generic Name
Ecallantide
Brand Names
Kalbitor
Application Number
BLA125277
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
ECALLANTIDE

Indications and Usage

1 INDICATIONS AND USAGE KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. ( 1 )