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Aurobindo receives FDA approval for mycophenolic acid DR tablets

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 DR Tablets USP, 180mg & 360mg.

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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 DR Tablets USP, 180mg & 360mg. Aurobindo Pharma’s Mycophenolic Acid DR Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Myfortic DR Tablets

manufactured by Novartis Pharmaceuticals Corporation.

Mycophenolic Acid DR 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. 

Mycophenolic Acid DR Tablets has an estimated market size of US $70 Million for the twelve months ending Dec 2023, as per IQVIA.

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