Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection
Amphastar Pharmaceuticals, Inc. recently announced that the US 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.
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.”
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.
Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the company sells insulin API products. Most of the company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. For more information, viait www.amphastar.com.
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