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Last Updated : Mar 11, 2019 04:47 PM IST | Source: PTI

Laurus Labs gets USFDA nod for malaria, auto-immune diseases drug

The company has received final approval from the United States Food and Drug Administration (USFDA) for Hydroxychloroquine tablets in the strength of 200 mg, Laurus Labs said in a filing to the BSE.

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Drug firm Laurus Labs on Monday said it has received approval from the US health regulator for its Hydroxychloroquine tablets used for treatment of malaria and certain autoimmune diseases.

The company has received final approval from the United States Food and Drug Administration (USFDA) for Hydroxychloroquine tablets in the strength of 200 mg, Laurus Labs said in a filing to the BSE.

The product is generic version of Concordia Pharmaceuticals Inc's Plaquenil tablets in the same strength, it added.

Hydroxychloroquine tablets are used for treatment of certain type of malaria. It is also used, usually with other medications, to treat certain autoimmune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used, Laurus Labs said.

"The company has also received a tentative approval for an abbreviated new drug application (ANDA) for Abacavir, Dolutegravir, and Lamivudine, tablets 600 mg/50 mg/300 mg from USFDA," it added.

The products will be commercialised from the company's manufacturing site located at Atchutapuram in Visakhapatnam, the company said.

Shares of Laurus Labs closed at Rs 363.85 per scrip on BSE, up 3.93 per cent from its previous close.
First Published on Mar 11, 2019 04:42 pm
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