Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Pre-Filled Syringes

Aug 16, 2022

RANCHO CUCAMONGA, CA / ACCESSWIRE / August 16, 2022 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's New Drug Application ("NDA") for Epinephrine injection USP, 1 mg/10mL (0.1 mg/mL) Single Dose Pre-Filled Syringe. Epinephrine injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. For the past 30 years, the Company has sold and marketed Epinephrine injection under the "grandfather" exception to the FDA's "Prescription Drug Wrap-Up" program. Net revenues for the Company's Epinephrine injection for the year ended December 31, 2021, were $27.8 million. Epinephrine injection is the final product that we market under the grandfather exception.

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