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.
