New Delhi: Drug firm Alembic Pharmaceuticals has received US health regulator’s final approval for two anti-hypertension tablets.
“The company has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets, 5 mg, 20 mg, and 40 mg and olmesartan medoxomil with hydrochlorothiazide tablets 20/12.5mg, 40/12.5mg and 40/25mg,” Alembic Pharmaceuticals said in a BSE filing today.
The approved products are therapeutically equivalent to the reference listed drug products Benicar and Benicar HCT of Daiichi Sankyo, which is used for the treatment of hypertension, it said. According to IMS sales data for the 12-month period ended December 2016, Benicar and Benicar HCT have an estimated market size of USD 1.8bn.
Shares of the company were trading at Rs 622, up 2.78 per cent on the BSE.