Friday, September 30, 2022

USFDA approves Zydus’ Mycophenolate Mofetil generic injection

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The US Food and Drug Administration granted Zydus Lifesciences Ltd a prior approval supplement to sell its generic version of Mycophenolate Mofetil for injection, which is used in conjunction with other medications to prevent organ rejection in patients undergoing renal, hepatic, or cardiac transplants.

The US Food and Drug Administration (USFDA) has authorised a Prior Approval Supplement (PAS) for Mycophenolate Mofetil for injection at a strength of 500 mg/vial, the generic equivalent of CellCept injection, according to a regulatory filing.

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.

Mycophenolate mofetil is approved for use in combination with other drugs including cyclosporine and corticosteroids to prevent organ rejection in patients who have had renal, hepatic, or cardiac transplants, according to the company. According to the corporation, since the filing procedure began in FY 2003-04, the organisation has received 330 approvals and filed over 400 shortened new medicine applications.

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