Benzinga | Mar 29, 2021 06:01AM EDT

Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection

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 Dextrose injection 50% in the 50 mL Luer-Jet(r) Prefilled Syringe System. For the past 40 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 Dextrose injection for the year ended December 31, 2020, were $7.6 million.



Amphastar's CEO and President, Dr. Jack Zhang, commented: "The FDA's approval of Dextrose, a product often on the Agency's Drug Shortage list, offers an opportunity to ensure quality products are produced at the highest standard and highlights Amphastar's manufacturing capabilities to fulfill such market needs."