Glatiramer

FDA Drug Profile — Glatiramer Acetate

Drug Details

Generic Name
Glatiramer
Brand Names
Glatiramer Acetate
Application Number
ANDA206936
Sponsor
Ambiopharm, Inc.
NDC Codes
2
Dosage Forms
POWDER, INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
GLATIRAMER, GLATIRAMER ACETATE

Indications and Usage

1 INDICATIONS AND USAGE Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).