New Delhi: Drug firm Lupin on Monday said it has received final approval from the US health regulator to market generic Nadolol tablets, used for the treatment of hypertension, in the American market.
The company has received final approval to market its Nadolol tablets USP, 20 mg, 40 mg and 80 mg from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.
The product is a generic version of US WorldMeds LLC’s Corgard tablets in the same strengths, it added.
As per IMS MAT June 2017 data, Nadolol tablets USP in the three strengths had annual sales of around USD 109.8 million in the US, Lupin said.
The tablets are indicated for the management of patients with angina pectoris and for the treatment of hypertension, it added.