Amphastar announced the U.S. Food and Drug Administration (FDA) has granted approval of its Abbreviated New Drug Application (ANDA) for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial. Amphastar’s newly approved drug product was determined by the FDA to be therapeutically equivalent to Adrenalin® (Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial) distributed in the United States by Par Pharmaceutical, Inc. Epinephrine Injection Multiple Dose Vial is for intramuscular, subcutaneous, and intravenous use, 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.
Additionally, the FDA granted 180 day exclusivity to Amphastar as the first generic filer.
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“We are pleased about the FDA’s approval of our Epinephrine Injection Multiple Dose Vial, which currently does not have any generic equivalent in the market. This approval expands the product offerings in our generic critical care injectable portfolio and highlights our commitment and internal capability of bringing generic injectable products to the market,” Amphastar’s CEO and President, Dr. Jack Zhang, said.
According to IQVIA™, U.S market annual sales for the 12 months ended December 31, 2019 for Epinephrine Injection, 30mg/30mL (1mg/mL) Multiple Dose Vial was approximately $ 131 million.