pasireotide

FDA Drug Profile — Signifor, Signifor LAR

pasireotide is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand names including Signifor, Signifor LAR. Available dosage forms: injection, kit, injection, powder, for suspension.

Drug Details

Generic Name
pasireotide
Brand Names
Signifor, Signifor LAR
Application Number
NDA200677
Sponsor
Recordati Rare Diseases, Inc.
NDC Codes
13
Dosage Forms
INJECTION, KIT, 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.