Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug


Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV). The company currently manufactures and distributes Enoxaparin Sodium Injection in prefilled syringe form, and this approval of the Multiple Dose Vial allows the company to begin offering the full line of Enoxaparin products. Amphastar’s newly approved product was determined by the FDA to be therapeutically equivalent to Lovenox (Enoxaparin Sodium Injection) MDV sold in the United States by Sanofi-Aventis. Amphastar plans to launch Enoxaparin MDV in the second quarter of 2019.

According to IQVIA, US market annual sales for the 12 months ended December 31, 2018 for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) MDV was approximately $11 million.

Pipeline Information
The company currently has four ANDAs filed with the FDA, which are targeting products with a market size of over $750 million, three biosimilar products in development targeting products with a market size of approximately $14 billion, and 11 generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2018. The company’s proprietary pipeline includes an NDA for intranasal naloxone. The company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.

Amphastar is a specialty pharmaceutical company that focuses 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, visit www.amphastar.com.

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