Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has announced its receipt of Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for calcium gluconate in sodium chloride injection, specifically in 1000 mg/50 mL and 2000 mg/100 mL formulations. This injectable product is currently listed on the U.S. FDA shortage product list.

The FDA granted this product approval with the Competitive Generic Therapy (CGT) designation, accompanied by a 180-day exclusivity period. Amneal boasts the highest number of CGT approvals in the U.S. generics industry.

Calcium gluconate in sodium chloride injection is a small volume parenteral bag used to treat acute symptomatic hypocalcemia in both pediatric and adult patients. It's crucial to note that concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates aged 28 days or younger.

"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," explained 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 ending in June 2023 totaled $107 million.