Jubilant Pharma Limited, a subsidiary of Noida-based Jubilant Life Sciences Ltd, has received Abbreviated New Drug Application (ANDA) final approval for Bupropion Hydrochloride Extended-Release Tablets USP (XL) (150 mg and 300 mg), which is used for the treatment of major depressive disorder.
Bupropion Hydrochloride is the generic version of Wellbutrin XL, a product of Valeant Pharmaceuticals International, which is also used as a smoking cessation aid.
Earlier, USFDA had approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products.
However following reports that patients who were switched from Wellbutrin XL 300 mg to its generic counterparts were experiencing reduced efficacy, the US drug regulator asked tablets manufactured by Impax and marketed by Teva to remove their genric version of Wellbutrin XL 300 mg after studies established that their drug was not therapeutically equivalent to Wellbutrin XL 300 mg.
This is the fourth approval Jubilant has received from the USFDA in 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.