Amneal Gets FDA Approval For Calcium Gluconate Injection

(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) Wednesday said it's Abbreviated New Drug Application for calcium gluconate in sodium chloride injection was approved by the U.S. Food and Drug Administration

The product approval received the FDA's Competitive Generic Therapy designation with 180-day exclusivity.

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.

"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.