Aurobindo Receives FDA Approval for Mycophenolate Mofetil Tablets USP, 500 mg
Published: February 20, 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 Mycophenolate Mofetil Tablets USP, 500 mg. Aurobindo Pharma’s Mycophenolate Mofetil Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Cellcept Tablets manufactured by Roche Palo Alto LLC.
Mycophenolate Mofetil Tablets are indicated for:
- The prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.