Australian company Acrux (ASX:ACR) has announced that the US FDA has approved its generic version of Rectiv (Nitroglycerin Ointment, 0.4%).
The product is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
The company said the annual addressable market sales for the product are growing and now exceed US$23 million.
The approval marks the sixth Acrux topical ANDA approved by the FDA.
Acrux CEO and managing director Michael Kotsanis said, “We are very pleased to receive FDA approval for another ANDA product which has been developed in house by the Acrux R&D team. This approval again demonstrates the capability of the Acrux team to execute the Company’s strategy to develop our pipeline of topical products.”
