MUMBAI: Cadila Healthcare on Saturday said its group firm Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) 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, stating that the drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, Gujarat.
The group currently has more than 140 approvals and has so far filed over 300 ANDAs. Earlier this week, the company had announced it had received a final nod from the US health regulator to market Donepezil Hydrochloride tablets used for the treatment of dementia of the Alzheimer’s type in the American market. These drugs are also set to be manufactured at the same plant and the announcement saw shares of the company rally as much as 2 per cent during intra-day trade on Friday.