- Acrux (ACR) receives approval from the US FDA to review a generic version of its nitroglycerin ointment at 0.4 per cent concentration
- The company applied for an abbreviated new drug application for the generic version, if approved by the FDA will allow ACR to market the generic ointment to patients
- Nitroglycerin ointment is used to treat moderate to severe pain associated with chronic anal fissures
- The total addressable market for the current product is almost US$19.9 million
- Shares rose 9.52 per cent to 4.6 cents at 12:59 pm AEST
Acrux (ACR) has received approval from the United States Food and Drug Administration (FDA) to review a generic version of its nitroglycerin ointment at 0.4 per cent concentration.
The company applied for an abbreviated new drug application for the generic version which, if approved by the FDA will allow ACR to market the generic ointment to patients.
Nitroglycerin ointment is used to treat moderate to severe pain associated with chronic anal fissures.
The original drug is currently listed as Rectiv Ointment, 0.4 per cent, and marketed by AbbVie in the US.
The total addressable market for the current product is almost US$19.9 million (A$29.7 million) with no FDA-approved generic version of the ointment available on the US market.
Acrux is currently advancing a variety of other topical products which are in varying stages of development, totalling 16 products.
Acrux shares rose 9.52 per cent to 4.6 cents at 12:59 pm AEST.