Jubilant gets USFDA nod for generic hypertension drug
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New Delhi: Jubilant Life Sciences on Wednesday said it has received approval from the US health regulator to market amlodipine and olmesartan medoxomil tablets, used to treat hypertension, in the American market.
Jubilant Pharma Ltd, a wholly-owned subsidiary of the company, has received abbreviated new drug application (ANDA) final approval for Amlodipine and Olmesartan Medoxomil in various strengths from the US Food and Drug Administration (USFDA), Jubilant Life Sciences said in a statement.
The company’s product is a generic version of Daiichi Sankyo’s Azor which is used for the treatment of hypertension.
“This is the third approval that we have received from the USFDA during the current financial year,” the Noida-based drug firm said.
As on 31 December 2016, Jubilant had a total of 73 ANDAs for oral solids filed in the US, of which 49 have been approved. The company’s shares were trading marginally down at Rs 760 on the BSE.