FDA approves Amneal Pharmaceuticals' ANDA for atovaquone oral suspension

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

Pneumocystis jiroveci pneumonia is a fungal infection of the lungs in people with a weakened immune system due to cancer, chronic use of corticosteroids or other medications that weaken the immune system, HIV/AIDS or organ or bone marrow transplant. 


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