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Aurobindo Receives FDA Approval for Mesalamine Extended-Release Capsules USP, 0.375 g

Published: March 31, 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 Mesalamine Extended-Release Capsules USP, 0.375 g. Aurobindo Pharma’s Mesalamine Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Apriso Extended-Release Capsules manufactured by Salix Pharmaceuticals, Inc.

Mesalamine Extended-Release Capsules are indicated for:

  • The maintenance of remission of ulcerative colitis in patients 18 years of age and older.