Lupin receives FDA approval for generic Benicar Tablets

Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg from the United States Food and Drug Administration (FDA) to market generic version of Benicar® tablets, 5 mg, 20 mg and 40 mg.

Lupin’s Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg are the AB rated generic equivalent of Daiichi Sankyo Inc.’s Benicar® tablets. It is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.

Benicar® tablets had US sales of USD 1,036 million (IMS MAT December 2016).