Acrux receives FDA approval for its generic testosterone topical solution

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Melbourne, Australia; 12 January 2021: Acrux Limited (ASX:ACR) (‘Acrux’ or the ‘Company’) is pleased to announce 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.

As announced on 12 October 2020, Acrux has 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 USD$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.

Authorised by the Board of Acrux Limited.

For more information, please contact:

General enquiries

 Michael Kotsanis Acrux Limited

CEO & Managing Director

P: + 61 3 8379 0100