Mumbai, July 9, 2007
Pharmaceutical and biotechnology major Wockhardt has received a tentative approval from the US FDA for marketing Fosphenytoin injections containing 50mg Phenytoin equivalents/ml. This injectible is used for treating complicated forms of epileptic seizures, where oral medicines cannot be administered.
Fosphenytoin is the generic name for the brand Cerebyx, sold in the US by Eisai Inc & Pfizer. As per IMS, the US market for Fosphenytoin injection is about $73 million.
Says Wockhardt chairman Habil Khorakiwala, “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 US”.
Wockhardt USA Inc currently markets 22 products in the US.
The Fosphenytoin injections are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra. This product was developed in-house.
Wockhardt Limited is a global pharmaceutical and biotechnology major with an innovative research and development programme. Wockhardt has global footprints and manufacturing organisations including UK, France, Germany, Ireland and USA. Wockhardt employs around 5,500 people worldwide
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