FDA accepts NDA filing for Allergan’s potential treatment for facial erythema

Allergan’s New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the US Food and Drug Administration (FDA) for standard review.

Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017. The NDA submission for oxymetazoline HCL cream 1.0% was based on data collected from two phase III pivotal clinical trials of a 29-day treatment duration and a one-year open label clinical trial.

These studies enrolled male and female patients over 18 years of age with moderate to severe persistent facial erythema associated with rosacea.