Amphastar Pharmaceuticals Receives FDA Approval for Morphine Sulfate Injection

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration approved the company’s Abbreviated New Drug Application (“ANDA”) for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled Syringe System. It is indicated for the management of pain severe enough to require use of an opioid analgesic by Patient-Controlled Analgesia (PCA), only for use with a compatible Alaris® infusion device, and for which alternative treatments are inadequate.

For the past 30 years, the company has sold and marketed the product under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the Company’s Morphine injection for the year ended December 31, 2020, were $2.3 million.

Amphastar’s CEO and President, Dr. Jack Zhang, commented: “The FDA’s approval of Morphine injection shows the Company’s continued commitment and ability to manufacture high quality injection products.”