1. USFDA: Glenmark Pharma gets nod for hypertension medicine

USFDA: Glenmark Pharma gets nod for hypertension medicine

Glenmark Pharmaceuticals has received final approval from the US health regulator for Amlodipine and Olmesartan Medoxomil tablets, used in the treatment of hypertension.

By: | New Delhi | Published: July 7, 2017 12:54 PM
Glenmark, Pharmaceuticals, USFDA Glenmark, USFDA, Glenmark Pharma, USFDA nod, hypertension medicine, US health regulator, treatment of hypertension, United States Food & Drug Administration According to IMS Health sales data for the 12 months to May 2017, Azor tablets achieved annual sales of approximately 1.6 million, Glenmark said. (Image/Reuters)

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 $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. Glenmark Pharmaceuticals’ shares were trading at Rs 666 per scrip on BSE, up 1.65 per cent.

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