Amneal Receives U.S. FDA Approval For Calcium Gluconate Injection; Key Injectable Currently On The U.S. FDA Shortage List; Received Competitive Generic Therapy Approval Designation
Portfolio Pulse from Happy Mohamed
Amneal Pharmaceuticals has received approval from the U.S. FDA for its calcium gluconate in sodium chloride injection, a product currently on the FDA shortage list. The approval received the FDA's Competitive Generic Therapy designation with 180-day exclusivity. The product is used for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients. U.S. annual sales for the product were $107 million for the 12 months ended June 2023.
September 06, 2023 | 8:00 pm
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POSITIVE IMPACT
Amneal Pharmaceuticals has received FDA approval for its calcium gluconate injection, a product on the FDA shortage list. This approval, along with the 180-day exclusivity, could potentially boost the company's revenues.
The FDA approval for a product on the shortage list means that Amneal Pharmaceuticals will be able to sell this product without much competition for 180 days. This could lead to increased sales and revenues for the company, positively impacting its stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100