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Corporate - Regulatory Bodies & Rulings
Wockhardt gets US nod for epileptic drug

Our Bureau

Mumbai, July 9

Wockhardt Ltd has received approval from the US Food and Drug Administration to market Fosphenytoin injections containing 50 mg Phenytoin equivalents/ml.

This injectible is used to treat complicated forms of epileptic seizures, where oral medicines cannot be administered, the company told the BSE.

Wockhardt USA Inc, the US subsidiary of the company, will launch Fosphenytoin in the US on August 6, 2007, a day after the patent expires on August 5, the company said.

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.

Wockhardt’s Chairman, Mr Habil Khorakiwala, said in the statement that Fosphenytoin will be its 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.”

Wockhardt USA Inc at present markets 22 products in the US.

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