Laurus Labs gets USFDA nod for malaria drug

Pharmaceutical manufacturer Laurus labs said it received final approval from the US Food and Drug Administration to launch a generic equivalent of Concordia Pharmaceuticals’ malaria drug Plaquenil.

Hydroxychloroquine is also used for treating diseases like rheumatoid arthritis and lupus and is sold under the brand name Axemal in India.

The company also received a tentative approval for selling Abacavir, Doultegravir and Lamivudine tablets in 50 mg, 300 mg and 600 mg doses. All these are medications used to prevent and treat HIV/AIDS.

Tentative approvals do not authorize its receiver to manufacture the drug immediately. However, they can manufacture and sell the drug as soon as the relevant patents expire without seeking further approvals.

Both the products will be manufactured at Laurus’ site at Atchutapuram in Vishakhapatnam.
Established in 2007, Laurus Labs sells its products in more than 56 countries. The company’s focus areas include drugs for the treatment of cancer and Hepatitis C.