The Mumbai-based pharma major Wockhardt Ltd has received the final approval for its anticonvulsant drug Divalproex sodium extended tablets 250 mg from the US Food and Drug Administration (FDA). The company has also bagged a tentative approval for the 500 mg ER tablets of the product.
The company officials announced that the Divalproex 250 mg ER tablets will be lauched in the US shortly. The 500 mg Divalproex ER tablets will be launched in early August 2009, after the 180-days exclusivity period accorded to Mylan.
The Divalproex sodium products are used for treating various kinds of epileptic seizures, bipolar disorders and migraine. Divalproex ER is the generic name for the brand Depakote ER, marketed in the United States by Abbott Laboratories. According to IMS, the total market for Divalproex ER tablets in the US is $910 million, of which the 250mg strength is $114 million.
"Divalproex sodium Extended Release tablets is a novel drug delivery system based product, indigenously developed by Wockhardt's R&D team," said Wockhardt chairman Habli Khorakiwala. "It is the strategic intent of Wockhardt to develop value-added generic products with novel / complex technologies. With nearly sixty products now in the market, Wockhardt's US business has seen a significant growth trajectory," he further added.
Wockhardt is one of the top 5 companies in the world to have received the highest number of 23 Abbreviated New Drug Approval (ANDA) by the US FDA for 2008 (source Generics Bulletin 2009).