Wockhardt has received final approval from the US FDA for marketing 100 mg, 150 mg and 200 mg 12-hour 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 US by Glaxo Smithkline. Wockhardt will launch the product soon. 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.
According to IMS Health, the total market for this product in the US 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. 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,” said Dr Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt.
EP News Bureau