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Acrux Ltd (ASX:ACR) has been approved to begin U.S. commercialisation activities for its Nitroglycerin Ointment 0.4% targeting pain related to chronic anal fissures, with this marking the fourth Acrux product approved by the FDA.
The ointment is a generic version of Rectiv and will be entering a market in which annual sales for the branded product and another generic competitor have exceeded US$23 million for the sale of 47,000 packs.
With the FDA notifying Acrux of the approval, and the product’s manufacture completed, the company will be able to see commercialisation activities unfold via its licensee TruPharma, which has organised its U.S. launch.
CEO and managing director Michael Kotsanis said it was notable for Acrux to have had an Abbreviated New Drug Application (ANDA) approved for the fourth time.
“We are excited to again commercially partner with TruPharma for another ANDA product
which has been developed in-house by the Acrux R&D team,” he said.
“This further demonstrates the capability of the Acrux team to execute the company’s strategy to develop and commercialise our pipeline of topical products.
“Commercial rights for the product are available for countries outside the United States.”
Acrux shares have risen following the news, and at 14:38 AEDT, they were trading at 3.3 cents – an increase of 3.13% since the market opened.
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