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Aurobindo Receives FDA Approval for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg

Published: February 27, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg. Aurobindo Pharma’s Mycophenolic Acid Delayed-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Myfortic Delayed-Release Tablets manufactured by Novartis Pharmaceuticals Corporation.

Mycophenolic Acid Delayed-Release Tablets are indicated for:

  • Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant.