FDA Accelerates Approvals of Generic Versions of HCQ

On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) 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... [Read More]

Source: The Rheumatologist - April 8, 2020 Category: Rheumatology Authors: U.S. Food and Drug Administration Tags: COVID-19 FDA generic drugs HCQ Hydroxychloroquine (HCQ) U.S. Food and Drug Administration (FDA) Source Type: research