Laurus Labs gets USFDA nod to Hydroxychloroquine tablets for treating malaria

Hydroxychloroquine tablet is also used, usually with other medications, to treat certain auto-immune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used.

New Delhi: Hyderabad-based, Laurus Labs gets final approval from the US health regulator for its Hydroxychloroquine tablets for treating malaria, 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.

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. Hydroxychloroquine tablets are used for treatment of malaria and certain autoimmune diseases.

Hydroxychloroquine is used to prevent or treat malaria infections caused by mosquito bites. It does not work against certain types of malaria (chloroquine-resistant). This medication is also used, usually with other medications, to treat certain auto-immune diseases (lupus, rheumatoid arthritis) when other medications have not worked or cannot be used. It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs).

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

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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.

The Company is one of the manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas. Laurus Labs also forayed into Finished Dosages Forms capabilities on the back of existing strengths in APIs.

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