FDA Approves NITROFURANTOIN — NorthStar Rx LLC

NorthStar Rx LLC received FDA approval for its Abbreviated New Drug Application (ANDA #216385) for oral nitrofurantoin, enabling the launch of a generic version of the antibiotic. This approval positions NorthStar to capture market share in a segment currently led by brand-name dominant Amoxicillin/Clavulanate, intensifying pricing pressure in the urinary tract infection landscape.