Zydus receives PAS approval from US FDA for Mycophenolate Mofetil for injection

Zydus Lifesciences has received Prior Approval Supplement (PAS) approval from the US Food and Drugs Administration (FDA) to market Mycophenolate Mofetil for injection USP, 500 mg/vial. The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat, a company statement said.

The PAS was for a site transfer into the Jarod site. This site was recently inspected by FDA. Earlier, in September 2017, the group was granted approval to market Mycophenolate Mofetil for injection in the strength of 500 mg/vial. Mycophenolate Mofetil is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants, it added.