Wockhardt gets US FDA approval for Fosphenytoin

Mumbai, July 10 (UNI) Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the US FDA for marketing Fosphenytoin injections which is used for treating complicated forms of epileptic seizures where oral medicines cannot be administered.

Wockhardt USA Inc., the US subsidiary of Wockhardt will be launching the Fosphenytoin in the US, on August 6 next month, a day after the patent expires on August 5. Fosphenytoin is the generic name for the brand Cerebyx, sold in the US by Eisai Inc and Pfizer.

The US market for Fosphenytoin injection is about million.

Speaking to reporters today, Wockhardt Chairman Habil Khorakiwala said, ''Fosphenytoin will be our third product to be launched on Day-1 after 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 22 products in the US, he informed.

UNI