The company states: “Amneal Pharmaceuticals announced it has received Abbreviated New Drug Application approval from the FDA for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL. This injectable product is currently on the U.S. FDA shortage product list. The product approval received the FDA’s Competitive Generic Therapy designation with 180-day exclusivity. Amneal has the highest number of CGT approvals in the U.S. Generics industry. According to IQVIA(R), U.S. annual sales for calcium gluconate in sodium chloride injection for the 12 months ended June 2023 were $107 million.”
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