New Epinephrine Injection Granted FDA Approval
This generic drug product was determined by the FDA to be therapeutically equivalent to Adrenalin.
Officials with the FDA have approved Amphastar Pharmaceuticals’ Abbreviated New Drug Application for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial, the company announced today.
This generic drug product was determined by the FDA to be therapeutically equivalent to Adrenalin® (Endo International and Par Pharmaceutical) and is indicated for emergency treatment of allergic reactions (Type 1), including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock, according to Amphastar. Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial is indicated for intramuscular, subcutaneous, and intravenous use.
Additionally, Amphastar was granted 180 day exclusivity as the first generic filer, the company reported in a press release. The company intends to launch this its generic drug product within 2-3 months.
According to IQVIA, market annual sales in the United States for the 12 months ending December 31, 2019 for epinephrine injection, 30mg/30mL (1mg/mL) multiple sose vial was approximately $ 131 million.
Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial [news release]. Rancho Cucamonga, CA; April 27, 2020: Amphastar website. http://ir.amphastar.com/news-releases/news-release-details/amphastar-pharmaceuticals-inc-receives-fda-approval-epinephrine Accessed April 27, 2020.