Zydus Lifesciences Ltd announced on Monday 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 undergoing 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 produced at the group’s injectables production site in Jarod, Gujarat, near Vadodara. The USFDA just reviewed this site “it was added In September 2017, the business received authorisation to commercialise Mycophenolate Mofetil for injection in a 500 mg/vial strength.
According to the business, mycophenolate mofetil is authorised for use in conjunction with other medications such as cyclosporine and corticosteroids for the prevention of organ rejection in patients having renal, hepatic, or cardiac transplants. The organisation currently has 330 approvals and has filed over 400 abbreviated new medication applications since the filing procedure began in FY 2003-04, according to the company.