New Delhi: Drug firm Jubilant Life Sciences said its subsidiary has received final approval from the US health regulator for Bupropion Hydrochloride extended- release tablets, used for the treatment of major depressive disorder and prevention of seasonal affective disorder.
“Jubilant Pharma Ltd. has received abbreviated new drug application (ANDA) final approval for Bupropion Hydrochloride extended-release tablets USP (XL), 150 mg and 300 mg,” Jubilant Life Sciences said in a BSE filing.
The approved product is the generic version of Wellbutrin XL of Valeant, which is used for the treatment of major depressive disorder and prevention of seasonal affective disorder.
This is the fourth approval received by the company from the USFDA during the current financial year.
As on March 31, 2017, Jubilant Life Sciences had a total of 81 ANDAs for oral solids filed in the US, of which 51 have been approved, the filing added.