FDA grants marketing approval to Zydus for generic mycophenolate mofetil injection
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The FDA has granted a prior approval supplement to Zydus Lifesciences Limited allowing the company to market its generic mycophenolate mofetil injection USP, 500 mg vial, following a transfer to a new manufacturing site.
According to a press release from Zydus, formerly known as Cadila Healthcare Ltd., the injection, listed in the United States under the name CellCept, will now be manufactured at the company’s facility at Jarod, near Vadodara in Gujarat, India. The prior approval supplement (PAS) was for a site transfer to the Jarod injectables manufacturing facility.
“This site was recently inspected by the U.S. FDA,” read the press release, in part. “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, including cyclosporine and corticosteroids, for the prevention of organ rejection in patients receiving renal, hepatic or cardiac transplants.
A PAS is a request to make changes to an already approved application, such as an abbreviated new drug application, which the FDA uses to approve generic drugs.
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