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Jun
25
ragupathyrenganathan
US FDA approves Amphastar Pharma’s Amphadase NDA
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The US Food and Drug Administration (FDA) granted approval to Amphastar Pharmaceuticals, Inc’s New Drug Application (NDA) supplement for Amphadase (hyaluronidase injection). This marks the first FDA approved starting material from the company’s subsidiary, ANP, located in Nanjing, China, and signifies that this facility has been qualified by the FDA.

Amphadase will compete in the hyaluronidase market, which had sales of $23 million for the 12 months ended March 31, 2015, according to IMS Health sales data. The product is used to improve the resorption of radiopaque agents. Amphastar plans to re-launch Amphadase in the fourth quarter of 2015.

Amphastar’s chief executive officer, Dr. Jack Zhang, Ph.D. stated, “We are very happy to have received approval of Amphadase. In addition to its monetary value, this approval further strengthens our vertical integration strategy, given that ANP will provide the key APIs and starting materials for our pipeline.”

The company currently has three abbreviated new drug applications (ANDAs), filed with the FDA targeting products with a market size of over $0.5 billion, and another ten generic products in development targeting products with a market size of over $15.0 billion. This market information is based on IMS Health sales data for the 12 months ended March 31, 2015. The company’s proprietary pipeline includes a new drug application (NDA) for Primatene. The company is currently developing six other proprietary drugs, including injectables, inhalation products, nasal sprays, and other dosage forms.

Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products.



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