Amphastar Pharmaceuticals, Inc. Receives FDA Approval for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial

RANCHO CUCAMONGA, Calif., April 27, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) (“Amphastar”), today announces that 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.