New Delhi, Oct 29 (PTI) Drug major Cipla Monday said it has received final approval from the US health regulator to market Metoprolol tablets, used to treat hypertension and various cardiac conditions.
The company has received final nod from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metoprolol ER tablets in the strengths of 50mg, 100mg and 200mg, Cipla said in a BSE filing.
The approved product is therapeutic equivalent version of Aralez Pharmaceuticals, Inc’s, Toprol XL, it added.
Cipla said, Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure, Angina Pectoris (chest pain or discomfort due to coronary heart disease).
Quoting IQVIA (IMS Health) data, Cipla said Toprol XL and its generic equivalents had US sales of around USD 464 million for the 12-month period ending August 2018.
Shares of Cipla were trading 3.52 per cent higher at Rs 624.70 apiece on the BSE.
This is published unedited from the PTI feed.