Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection

RANCHO CUCAMONGA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System. For the past 40 years, the Company has sold and marketed the product under the “grandfather” exception (now termed “unapproved”) to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the Company’s Atropine Sulfate injection for the year ended December 31, 2019 were $12.2 million.

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