Amphastar receives FDA green light for dextrose injection

The Food and Drug Administration has given its blessing to Amphastar Pharmaceuticals for dextrose injection 50% in the 50-ml Luer-Jet Prefilled Syringe System.

The medication is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection as a fluid and nutrient replenisher.

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 Dec. 31, 2020, were $7.6 million.

“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," said Jack Zhang, Amphastar president and CEO.