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.
