The US Food and Drug Administration has confirmed 180 days of generic market exclusivity for Eagle Pharmaceuticals’ generic to Par’s Vasostrict (vasopressin) 20 units/ml injectable, allowing for a tentative approval to be handed to Amphastar Pharmaceuticals for its Vasostrict ANDA product.
Eagle Bags Vasopressin Exclusivity And Details Launch Plans
US Agency Also Dishes Out Tentative Nod For Amphastar’s’ ANDA Product
Generic competition to Vasostrict is nearing in the US after the FDA confirmed Eagle’s previously unresolved potential for 180-day market exclusivity.
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