Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“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 (“CGT”) designation with 180-day exclusivity. Amneal has the highest number of CGT approvals in the U.S. Generics industry.
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. Key Warning: Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger.) For full prescribing information, see package insert located here.
“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, Amneal Biosciences.
According to IQVIA®, U.S. annual sales for calcium gluconate in sodium chloride injection for the 12 months ended June 2023 were $107 million.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.