Acrux Limited (ASX:ACR) (OTCMKTS:ARUXF)) has received US Food and Drug Administration (FDA) approval for its generic product based on Perrigo’s Testosterone Topical Solution.
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 in 30mg/1.5ml strength.
The FDA has notified Acrux that the submission has now been approved and that Acrux can manufacture and market the generic drug.
“A major milestone”
Acrux CEO and managing director Michael Kotsanis said: “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.”
Agreement with Dash Pharmaceuticals
In October last year, Acrux has entered into an exclusive sales, marketing and distribution agreement with Dash Pharmaceuticals.
As per the agreement, Dash will be responsible for commercialisation of the product in the United States, including the coordination of commercial manufacturing and management of marketing and distribution.
Total annual sales in the 12 month period to the end of September 2020 in this segment, which is Acrux’s generic segment, were more than US$25 million, based on IQVIA data.
Acrux and Dash will share the profits generated from the sales of the product.
Kotsanis said: “We are excited to partner with Dash Pharmaceuticals to bring this product to market in the current financial year.”
The company is dedicated to the developing and commercialising topical pharmaceuticals.
Incorporated in 1998, Acrux has successfully developed and commercialised through licensees a number of topically applied pharmaceutical products in the US and Europe.