Allergan Says FDA Accepts Its NDA Filing Of Oxymetazoline HCI Cream 1.0%

Allergan plc AGN revealed Tuesday that the FDA has accepted its New Drug Application (NDA) filing for its oxymetazoline HCl cream 1.0% for standard review. According to the company, this is an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults.

Allergan said it expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of the next year.

The company's Chief R&D Officer, David Nicholson, said, "While rosacea is a common chronic skin condition that affects more than 16 million people in the U.S. alone1, there is a significant unmet need in effective, FDA-approved treatments for the condition."

He continued to add, "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."

In the pre-market trading on Tuesday, the stock traded 0.44 percent up.