The approval is for Mycophenolate Mofetil injection of strength 500mg/vial
Cadila Healthcare said its group firm Zydus Cadila has received final approval from the US FDA to market Mycophenolate mofetil for injection used in organ transplants to prevent rejection.
The approval is for Mycophenolate Mofetil injection of strength 500mg/vial, the company said in a BSE filing.
The drug is indicated for use in combination with other drugs —— cyclosporine and corticosteroids for prophylaxis of organ rejection in patients receiving kidney, liver or heart transplants, it added.
It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, the company said.
The group now has more than 140 approvals and has so far filed over 300 ANDAs, the filing said.