Zydus Lifesciences Ltd. on Monday said that it has received final approval from the United States Food and Drug Administration (USFDA) for Icosapent Ethyl capsules, which are used in the treatment of heart diseases.

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In a filing to the stock exchanges, the pharma major said that it has received final approval from the US drug regulator for Icosapent Ethyl capsules in the strength of 0.5 g and 1 g.

The recently approved tablets are used to reduce fat (triglyceride) levels in the blood in adult patients with severe hypertriglyceridemia.

Hypertriglyceridemia is the presence of too many triglycerides or fats in your blood. This raises your risk of atherosclerosis and related heart diseases.

As per the IQVIA data for 12 months ending February 2023, Icosapent Ethyl Capsules, 0.5g, and 1g had annual sales of $1,316 million in the United States.

With this, the company has now received 365 approvals and has so far filed over 440 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

So far, the Ahmedabad-headquartered company has received a US regulator nod for a total of eight drugs, ranging from Icosapent Ethyl, Metoprolol Tartrate, Roflumilast, Estradiol Transdermal, Isoproterenol Hydrochloride Injection, Tavaborole Topical Solution, Azithromycin Tablets to Carbidopa and Levodopa.

Shares of Zydus Lifesciences are trading 0.4 percent lower at Rs 520.90.

First Published:Apr 24, 2023 11:12 AM IST