Zydus Lifesciences has received final approval from the USFDA for manufacturing and marketing Metoprolol Tartrate Tablets USP, 25 mg, 50 mg, and 100 mg.
This is the seventh drug approval that the company has received over the last three weeks.
The recently approved tablets are used with or without other medications to treat high blood pressure (hypertension). This medication is also used to treat chest pain (angina) and to improve survival after a heart attack.
Metoprolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in body, such as epinephrine, on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.
The drug will be manufactured at Zydus Life’s formulation manufacturing facility in Baddi, Himachal Pradesh.
Metoprolol Tartrate Tablets USP, 25 mg, 50 mg, and 100 mg had annual sales of $45.2 million in the United States, as per the IQVIA data of February 2023.
With this approval, Zydus Life now has total 364 approvals and has so far filed more than 440 ANDAs since the commencement of the filing process in financial year 2003-04.
So far, the Ahmedabad-headquartered company has received US regulator nod for total seven drugs, ranging from Metoprolol Tartrate, Roflumilast, Estradiol Transdermal, Isoproterenol Hydrochloride Injection, Tavaborole Topical Solution, Azithromycin Tablets to Carbidopa and Levodopa.
Shares of Zydus Lifesciences are trading 1.6 percent lower at Rs 508.60. The stock is up 21 percent so far this year.
(Edited by : Hormaz Fatakia)