Zydus Lifesciences Receives US FDA PAS Clearance for Generic Injection

Zydus Lifesciences has received Prior Approval as a Supplement (PAS) from the United States Food and Drug Administration to commercialize Mycophenolate mofetil for Injection USP, 500 mg/vial.

The product, of which the reference drug is CellCept Injection, is manufactured at the Group’s injectable manufacturing facility in Jarod, near Vadodara, Gujarat. The Prior Approval Supplement (PAS) was for a site transfer to the Jarod site. That site was recently inspected by the US Food and Drug Administration, Zydus said Monday.

Mycophenolate mofetil is indicated in combination with other medicinal products for the prevention of organ rejection in patients undergoing kidney, liver or heart transplantation. A PAS is an application that aims to make changes to an already approved application, such as:

In September 2017, the group received approval to commercialize mycophenolate mofetil for injection at a strength of 500 mg/vial, Zydus said. The company’s shares closed 1.77% lower at £366.60 a share.

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