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news.FDA has accepted for substantive review of Acrux's new drug application for Axiron which was submitted in January 2010. Axiron, is Acrux's testosterone therapy to treat hypogonadism in men.
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Acrux is an Australian drug delivery company, developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin.
Earlier, in March 2010, Acrux and Eli Lilly had entered into an exclusive global licensing agreement, under which Lilly acquired worldwide rights to commercialise Axiron. The upfront payment of $50m due under the terms of the agreement has been received by Acrux.
Richard Treagus, CEO of Acrux, said: “This is another important milestone for Axiron and Acrux. We look forward to working with the FDA and Lilly during the ongoing review of our application.”