Allergan's rosacea treatment NDA accepted by FDA

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) from Allergan for a cream to treat symptoms of rosacea in adults, the company announced this week.

This cream is made with oxymetazoline HCl. Prior to submitting the NDA, the company had completed two Phase III clinical trials that consisted of 29-day treatments and a year-long open label clinical trial.

"While rosacea is a common chronic skin condition that affects more than 16 million people in the U.S. alone, there is a significant unmet need in effective, FDA-approved treatments for the condition," Chief R&D Officer at Allergen David Nicholson said. "The NDA filing of oxymetazoline speaks to our strong commitment to ongoing innovation of our medical dermatology portfolio, and we look forward to bringing a new treatment option to patients with rosacea."  

The company states that this product will have a Prescription Drug User Fee Act (PDUFA) date in the first half of 2017.

Rosacea is a skin condition that can result in rashes, breakouts similar to acne and overall skin sensitivity.