Mumbai, June 14 (IANS) India's leading pharmaceutical and biotechnology firm Wockhardt Ltd Wednesday said it has received an approval from the Food and Drug Administration (FDA) of the US for its anti-epileptic drug Divalproex Sodium.
The patent for Divalproex Sodium expires Jan 29, 2008. The company's US subsidiary Wockhardt USA Inc will launch it on the first day of the patent expiration in the US market.
"The market for the product in the US is $802 million, as per IMS data, Divalproex Sodium is the generic version of Abbott's Depakote DR tablets," a Wockhardt official said here.
"Approval for an NDDS (novel drug delivery system) product by the FDA is a tribute to the technical skills of our research and regulatory teams," said Wockhardt chairman Habil Khorakiwala.
Divalproex Sodium will be manufactured at the active pharmaceutical ingredient facility at Ankleshwar in Gujarat and the tablets at the formulation plant in Aurangabad, both certified by the FDA.