Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection
- Amneal Pharmaceuticals has received FDA approval for calcium gluconate injection, which is currently on the shortage list. The approval comes with 180-day exclusivity under the Competitive Generic Therapy designation. Amneal aims to address immediate patient needs and long-term shortages in the market.
- According to IQVIA®, U.S. annual sales for calcium gluconate injection were $107 million for the 12 months ended June 2023.
- None.
- Key injectable currently on the
- Received Competitive Generic Therapy approval designation
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
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®,
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Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
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Investor Contact
Anthony DiMeo
Head of Investor Relations
anthony.dimeo@amneal.com
Source: Amneal Pharmaceuticals, Inc.