Amneal gets OK for FDA shortage product

 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.

https://finance.yahoo.com/news/amneal-receives-u-fda-approval-200000568.html