New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for Amlodipine and Olmesartan Medoxomil tablets, used in the treatment of hypertension.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Amlodipine and Olmesartan Medoxomil tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg,” the company said in a BSE filing.
The approved product is a generic version of Daiichi Sankyo’s Azor.
According to IMS Health sales data for the 12 months to May 2017, Azor tablets achieved annual sales of approximately USD 211.6 million, Glenmark said.
The company’s current portfolio consists of 119 products authorised for distribution in the US marketplace and 66 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.