Zydus Lifesciences Limited, on Tuesday, received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Metronidazole Topical Cream, 0.75 per cent.
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It is expected to help decrease redness, swelling, and the number of pimples caused by rosacea and is believed to work by decreasing swelling (inflammation).
In a filing with the stock exchanges, Zydus Lifesciences said, the drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).
Metronidazole Topical Cream, 0.75 per cent had annual sales of $25 million in the US. The group now has 366 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
On Monday, the company said it has received approval from the US health regulator to market a generic medication that is used to lower triglycerides, in the American market.
The company has got the final approval from USFDA to market Icosapent Ethyl Capsules in strength of 0.5 g and 1 g, it said in a regulatory filing.
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The capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.