Laurus Labs said it had received the final approval from the US Food and Drug Administration (USFDA) for Hydroxychloroquine tablets 200 mg, a product used in the treatment of certain types of malaria.
The company has also received tentative approval from the regulator for an ANDA (Abbreviated New Drug Application) for Abacavir, Dolutegravir, and Lamivudine tablets 600 mg/50 mg/300 mg, a fixed dose combination product indicated for HIV infection.
The products would be commercialised from Laurus’ manufacturing site at Atchutapuram, Visakhapatnam, the company said.
Hydroxychloroquine tablets, which are therapeutically equivalent to Plaquenil tablets 200mg of Concordia Pharmaceuticals Inc, 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 company said in the statement.
