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Aurobindo Receives FDA Approval for Linaclotide Capsules, 145 mcg and 290 mcg

Published: February 07, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Linaclotide Capsules, 145 mcg and 290 mcg. Aurobindo Pharma’s Linaclotide Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), LINZESS® (linaclotide) Capsules manufactured by Allergan Sales, LLC.

Linaclotide Capsules are indicated in adults for:

  • The treatment of irritable bowel syndrome with constipation (IBS-C)
  • The treatment of chronic idiopathic constipation (CIC).