Acrux (ASX:ACR), a leading Australian specialty pharmaceutical company, has secured US FDA approval for its sixth Abbreviated New Drug Application (ANDA) with a generic version of Rectiv® (Nitroglycerin Ointment, 0.4%). This product targets moderate to severe pain from chronic anal fissures, marking a significant step forward in Acrux's US market strategy.
Acrux has achieved a pivotal milestone with the FDA's approval of its generic version of Rectiv® Ointment, showcasing the company's expertise in developing topical generics. This development is part of Acrux's broader strategy to expand its range of affordable topical products within the US pharmaceutical market. The growing annual addressable market for this product in the United States exceeds USD$23 million, reflecting strong demand. Acrux's commitment to innovation is further demonstrated by this being its sixth ANDA approval, reinforcing its presence in the competitive US generics sector. The company aims to continue its trajectory of growth and seeks to explore further collaboration opportunities and product development initiatives.
We are very pleased with the FDA approval of our sixth topical ANDA. This approval is a testament to our strategy and the strength of our R&D team.