Drug maker Granules India on Friday said it has received approval from the US health regulator to market a generic medication to treat major depressive disorder.
The abbreviated new drug application (ANDA) for the product was filed with the USFDA by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, it added.
Drug maker Granules India on Friday said it has received approval from the US health regulator to market a generic medication to treat major depressive disorder.
The company has received approval from the US Food & Drug Administration (USFDA) for Bupropion Hydrochloride extended-release tablets USP (SR) in strength of 100 mg, 150 mg, and 200 mg, the Hyderabad-based drug maker said in a statement.
The abbreviated new drug application (ANDA) for the product was filed with the USFDA by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, it added.
Bupropion Hydrochloride extended-release tablets USP (SR) are bioequivalent and therapeutically equivalent to GlaxoSmithKline LLC's Wellbutrin SR sustained-release tablets, Granules India said.
The medication is widely prescribed for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.
Granules said it has now a total of 67 ANDA approvals from the USFDA.
"This ANDA approval marks a significant milestone in our journey to expand the company's presence in the US market," Granules India Chairman and Managing Krishna Prasad Chigurupati stated.
The company's continued focus on expanding product portfolio in regulated markets like the US ensures that it is meeting the growing healthcare needs of patients globally, he added.
Shares of Granules India were trading 0.72 per cent up at Rs 597.55 apiece on the BSE.