FDA approves ANDA for hydroxychloroquine in malaria, lupus and RA

8 April 2020

Among several actions take this week in in its ongoing response effort to the COVID-19 pandemic, the Food and Drug Administration approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200mg. for the treatment of:

Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax.
(2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and
(3) Treatment of acute and chronic rheumatoid arthritis in adults.

The ANDA was submitted by Accord Healthcare, a UK-based subsidiary of Indian biopharma company Intas Pharmaceuticals. The FDA did not in this instance approve the drug for the treatment of the new coronavirus.

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