Acrux Limited (ASX:ACR) reports that the US Food and Drug Administration (FDA) has approved its generic product based on Perrigo’s Testosterone Topical Solution, 30mg/1.5mL.
In August 2018, Acrux submitted an Abbreviated New Drug Application (ANDA) to seek approval from the FDA to market a generic product equivalent to Perrigo’s Testosterone Topical Solution, 30mg/1.5mL. The FDA has notified Acrux that the submission has now been approved and that Acrux can manufacture and market the generic drug.
Acrux announced in October 2020 that it had entered into an exclusive sales, marketing and distribution agreement with Dash Pharmaceuticals (Dash). Dash will be responsible for the commercialisation of the product in the United States, including the coordination of commercial manufacturing and management of marketing and distribution.
In the United States, sales generated by the product with which Acrux’s generic will compete exceeded US$25 million in the 12 months to the end of September, 2020, based on IQVIA data.
Acrux and Dash will share the profits generated from the sales of the product.
FDA approval is a major milestone for Acrux and its generics strategy. It is a testament to the hard work and dedication of the product development and regulatory team. We are excited to partner with Dash Pharmaceuticals to bring this product to market in the current financial year,” Acrux CEO and Managing Director, Michael Kotsanis, said.