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BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.
Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.
Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.
Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.