pasireotide

FDA Drug Profile — Signifor LAR, Signifor

Drug Details

Generic Name
pasireotide
Brand Names
Signifor LAR, Signifor
Application Number
NDA203255
Sponsor
Recordati Rare Diseases, Inc.
NDC Codes
13
Dosage Forms
KIT, INJECTION, INJECTION, POWDER, FOR SUSPENSION
Routes
SUBCUTANEOUS
Active Ingredients
PASIREOTIDE

Indications and Usage

1 INDICATIONS AND USAGE SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. ( 1.1 ) Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. ( 1.2 ) 1.1 Acromegaly SIGNIFOR LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 1.2 Cushing's Disease SIGNIFOR LAR is indicated for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.