Aurobindo Receives FDA Approval for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL
Published: September 26, 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 for Oral Suspension USP, 200 mg/mL. Aurobindo Pharma’s Mycophenolate Mofetil for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), CELLCEPT® Oral Suspension manufactured by Roche Palo Alto, LLC.
Mycophenolate Mofetil for Oral Suspension 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.