Wockhardt gets FDA nod

Wockhardt has received a tentative approval from the US Food and Drug Administration (FDA) for marketing Fosphenytoin injections in 50 mg or equivalent liquid dosages, used for treating complicated forms of epileptic seizures.

Fosphenytoin is the generic name for the brand Cerebyx, sold in the US by Eisai and Pfizer. According to IMS, the US market for Fosphenytoin injection is about $73 million.

Wockhardt USA, the US subsidiary of Wockhardt, would launch the drug in that country on August 6, a day after the patent expiry of the drug, said Wockhardt.

"Fosphenytoin will be our third product to be launched on day one after patent expiry and 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," said Chairman Habil Khorakiwala. Wockhardt USA markets 22 products in the US.