Jubilant Life Sciences said it received final approval from US authorities to launch a generic version of Valeant’s anti-depressant Wellbutrin.
The approval from FDA is for introducing Bupropion Hydrochloride tablets in 150 mg and 300 mg doses.
The drug is used for the treatment of major depressive disorder and prevention of seasonal affective disorder.
“This is the fourth approval that we have received from the USFDA during the current financial year,” the Indian company said.
As on March 31, 2017, Jubilant Life Sciences had a total of 81 abbreviated applications — used for generic drugs — for tablets filed with US authorities, of which 51 have been approved.
Jubilant Life Sciences offers pharmaceuticals, life science ingredients and drug discovery solutions.
It manufactures active pharmaceutical ingredients, formulations, radiopharmaceuticals, allergy products and undertakes contract manufacturing of sterile and non-sterile products.
The company has six USFDA approved manufacturing facilities in India, USA and Canada.
In Life Sciences, the company offers specialty intermediates, nutritional products and life science chemicals.