linaclotide

FDA Drug Profile — Linzess

Drug Details

Generic Name
linaclotide
Brand Names
Linzess
Application Number
NDA202811
Sponsor
Allergan, Inc.
NDC Codes
8
Dosage Forms
CAPSULE, GELATIN COATED, POWDER
Routes
ORAL
Active Ingredients
LINACLOTIDE

Indications and Usage

1 INDICATIONS AND USAGE LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 6 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. ( 1 ) Chronic idiopathic constipation (CIC) in adults. ( 1 ) Functional constipation (FC) in pediatric patients 6 years of age and older. ( 1 )