Acrux Limited (ASX:ACR) Receives FDA Approval for Nitroglycerin Ointment
FDA Approval Received
Acrux Limited (ASX:ACR) has announced the US Food and Drug Administration (FDA) approval of its sixth Abbreviated New Drug Application (ANDA), a generic version of Rectiv® (Nitroglycerin Ointment, 0.4%). This product is indicated for treating moderate to severe pain associated with chronic anal fissures.
Market Potential
The annual addressable market sales for Nitroglycerin Ointment now exceed USD$23 million, indicating healthy growth potential in the sector. There are over 47,000 packs sold in the United States based on IQVIA sales data.
Executive Comments
Michael Kotsanis, CEO and Managing Director of Acrux, expressed satisfaction with the FDA’s decision, stating, “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.”
Company Overview
Acrux is a specialty pharmaceutical company focused on developing and commercialising topically applied pharmaceutical products. With 25 years of experience, it leverages its expertise to bring affordable products to market and is open to collaboration and product development opportunities.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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