Wockhardt gets nod for Fosphenytoin

Indian pharma major Wockhardt has received the US FDA approval for marketing fosphenytoin injections.

This injectable is used for treating complicated forms of epileptic seizures, where oral medicines cannot be administered.

The injection will contain 50 mg phenytoin equivalents/ ml.

Wockhardt USA Inc, the US subsidiary, will be launching the fosphenytoin in the US, in August this year. Fosphenytoin is the generic name for the brand Cerebyx, sold in the US by Eisai Inc and Pfizer. As per IMS, the US market for fosphenytoin injection is about $73 million.

Habil Khorakiwala, chairman, Wockhardt, said, "Fosphenytoin will be our third product to be launched on Day-1 after its patent expiry. It is a very significant addition to our sterile portfolio for the US market. Now with six injections being marketed by us, our varied portfolio will enable us to expand our presence in the United States".

Wockhardt USA Inc currently markets twenty-two products in the US.

The fosphenytoin injections are manufactured at the USFDA certified formulation plant at Waluj, Maharashtra. This product was developed in-house by the company.