Indian pharma company Zydus Lifesciences announced that it has received a Prior Approval Supplement (PAS) nod from the U.S. Food and Drug Administration (USFDA) to market its generic version of Mycophenolate Mofetil of injection.
The drug is used in combination with other medicine for prophylaxis of organ rejection in patients who receive kidney, liver, or heart transplants. It belongs to a class of drugs called immunosuppressants.
The USFDA granted PAS for generic Mycophenolate Mofetil for injection of strength 500 mg/vial, which is equivalent to CellCept injection, according to Zydus.
A PAS is an application that seeks to make changes to an already-approved application, like an Abbreviated New Drug Application (ANDA), which is used by the FDA to approve generic drugs. It refers to a change in either manufacturing or testing of a product that requires the agency’s approval prior to implementation of any changes or sale of the product.
Zydus said the PAS that it has received is for site transfer into Jarod.
The company said, “The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat. This site was recently inspected by the USFDA.”
Mycophenolate Mofetil is used in combination with other medicine like cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving kidney, liver, or heart transplants.
So far, the company has 330 approvals and filed over 400 ANDAs.
CellCept is a brand name of Mycophenolate Mofetil, which was approved by the FDA in the form of a capsule, suspension, tablet, and injection. The FDA approved CellCept injection in Augusta 1998.
Genentech, Inc., an American biotechnology corporation that became a subsidiary of Roche in 2009, develops CellCept.
