Zydus Lifesciences Ltd announced that it has received a prior approval supplement nod from the US Food and Drug Administration to market its generic version of Mycophenolate Mofetil for injection, which is used in combination with other drugs to prevent organ rejection in patients receiving renal, hepatic, or cardiac transplants. According to a regulatory filing, the US Food and Drug Administration (USFDA) approved a Prior Approval Supplement (PAS) for Mycophenolate Mofetil for injection at a strength of 500 mg/vial, the generic counterpart of CellCept injection.
According to the USFDA, a PAS is a modification in the manufacture or testing of a product that applies to either a single batch of product or all goods and requires the regulator’s permission prior to implementation or sale of the product. According to the corporation, the PAS it has obtained is for a site move into Jarod.
The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara which was recently inspected by USPA. 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 the financial year, 2003-04. The group was granted approval to market for Mycophenolate Mofetil for injection in the strength of 500 mg/vial in the September of 2017. Mycophenolate Mofetil will be used in combination with other drugs such as cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic, or cardiac transplants.
