ACRUX LIMITED Acrux Limited announced that the US Food and Drug Administration (FDA) has accepted for review Acrux's application for a generic version (Abbreviated New Drug Application or `ANDA') of cold sore treatment, Acyclovir Cream, 5%. 1. The company has submitted an ANDA to seek approval from the FDA to market its generic version of cold sore treatment Acyclovir Cream, 5%. The FDA has notified Acrux that the application is sufficiently complete to be accepted for review.
The reference listed drug is Zovirax® Cream, 5% which is marketed by Bausch Health in the United States. While the FDA administers the review process, the time to ultimate approval is influenced by the number and nature of questions which may arise as the FDA progresses their review. Once the FDA has granted approval, Acrux can finalise preparations with its contracted commercial partner to commence marketing and sales of the product in the United States.
