Amneal has received the Food and Drug Administration’s permission for calcium gluconate in sodium chloride injection, 1000 mg/50 ml and 2000 mg/100 ml.
The product received the FDA’s Competitive Generic Therapy designation with 180-day exclusivity, and it is currently on the FDA shortage product list, Amneal noted.
Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients.
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“The approval of calcium gluconate injection, a key injectable in shortage, reflects our commitment to addressing immediate patient needs for essential medicines. This is part of our concerted strategy to address long-term shortages in the market. We look to partner with our customers to deliver these essential medicines to providers who need them and the patients they serve,” said Harsher Singh, senior vice president of Amneal Biosciences.
Calcium gluconate in sodium chloride injection had a market value of $107 million for the 12 months ended June 2023, per IQVIA.
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