PARSIPPANY, N. J. and MUMBAI, India, Sept. 4, 2012 Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 100 mg, 150 mg and 200 mg 12-Hr extended release tablets of Bupropion HCl which is used in the treatment of depression. Bupropion is the generic name for the brand Wellbutrin SR, marketed in the U.S. by Glaxo Smithkline. Wockhardt is launching the product immediately.
According to IMS Health, the total market for this product in the U.S. is about $268 million. Depression is a rapidly growing condition globally and Bupropion is one of the more used drugs for treating this condition.
"This is our sixth ANDA approval in past two weeks and Bupropion SR 12-Hr is yet another product based on extended-release technology," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "Extended Release technology is a core competency of Wockhardt's R&D and they have consistently risen to the challenge of developing these technically challenging products," he added.
In the U.S. generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the extended release tablets of Bupropion 12-Hr at its facility in Waluj, India. The technology for the tablets was developed in-house.
PR Newswire