SUPPLIER NEWS — 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 generic version of Furadantin, 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.
The FDA has approved a generic drug for epilepsy made by Mylan. Mylan said that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures. Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.
The FDA has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said. The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before. The drug belongs to a class known as non-nucleoside reverse transcriptase inhibitors, or NNRTIs, and is designed for use as part of a highly active antiretroviral therapy, or HAART, regimen.