Hyderabad-based Laurus Labs Limited said announced on Monday that it has received a final approval from the US Food and Drug Administration(US FDA) for Hydroxychloroquine tablets 200 mg, which is used for treatment of certain types of Malaria.
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. The drug is a therapeutic equivalent of Plaquenil tablets of Concordia Pharmaceuticals, Inc.
In another development, the company also received a tentative approval for an abbreviated new drug application (ANDA) for Abacavir, Dolutegravir and Lamivudine Tablets of 600 mg/50 mg/ 300 mg from the US FDA. The product will be commercialised from Laurus' manufacturing site located at Atchutapuram in Visakhapatnam.