Global pharma major Lupin Limited on Tuesday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Doxycycline Capsules, 40 mg, to market a generic equivalent of Oracea Capsules, 40 mg, of Galderma Laboratories, L.P.
Doxycycline is a broad-spectrum tetracycline-class antibiotic used in the treatment of infections caused by bacteria and certain parasites. It is indicated for bacterial infections, such as acne, urinary tract infections, intestinal infections, respiratory infections, eye infections, gonorrhea, chlamydia, syphilis, periodontitis (gum disease), and others.
Doxycycline stops the growth of bacteria when treating bacterial infections and reportedly it also has an anti-inflammatory action when used for other conditions.
Moreover, some forms of doxycycline are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of USD 215 million in the U.S., as per IQVIA MAT September 2022.