Amphastar Pharmaceuticals Receives Approval for Amphadase Supplement

The U.S. Food and Drug Administration (FDA) granted approval of the Amphastar Pharmaceuticals’ 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.

“We are very happy to have received approval of Amphadase,” said Amphastar’s chief executive officer, Jack Zhang. “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.”