Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection
06 Setembro 2023 - 5:00PM
Business Wire
- Key injectable currently on the U.S. FDA shortage list -
Received Competitive Generic Therapy approval designation
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.
About Amneal 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.
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Investor Contact Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
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