AGN 199201 (oxymetazoline HCl cream) filed with the FDA for rosacea - Allergan
Allergan announced that the New Drug Application filing for AGN 199201 (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 FDA for standard review. Allergan expects the Prescription Drug User Fee Act 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 1-year open label clinical trial. These studies enrolled male and female patients = 18 years of age with moderate to severe persistent facial erythema associated with rosacea.
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