Amphastar Receives FDA Approval for Dextrose Injection

Amphastar Pharmaceuticals announced 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® 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.

“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,” Amphastar’s CEO and President, Dr. Jack Zhang, said.

The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately $2.3 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and seven generic products in development targeting products with a market size of approximately $10.5 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2020. The Company is currently developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.