Zydus gets US regulator’s PAS for generic version of Mycophenolate Mofetil for injection

PTI, Mar 21, 2022, 10:46 AM IST

New Delhi: Zydus Lifesciences Ltd on Monday said it has received prior approval supplement nod from the US health regulator to market its generic version of Mycophenolate Mofetil for injection used in combination with other drugs for prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants.

The Prior Approval Supplement (PAS) granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for injection of strength 500 mg/vial, the generic equivalent of CellCept injection, the company said in a regulatory filing.

As per the USFDA, PAS refers to a change in either manufacturing or testing of a product applicable to either a specific batch of product or all products that requires the regulator’s approval prior to implementation of such changes or sale of the product.

The company said the PAS it has received is for site transfer into Jarod. ”The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat. This site was recently inspected by the USFDA,” it added.

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 such as cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants, the company said. The group now has 330 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in FY 2003-04, it added.