FDA Approves Valeant Pharmaceuticals' Onexton Gel for the Treatment of Acne Vulgaris

Valeant Pharmaceuticals International, Inc. has received approval from FDA for Onexton Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older. Acne vulgaris is a common skin disorder that affects 40 to 50 million people in the US.

"We are very pleased that FDA has approved this new dual action medication that gives physicians and patients a new option for the topical treatment of acne vulgaris," said J. Michael Pearson, chairman and CEO. "Onexton is the fourth product to be approved in our medical dermatology business in the past twelve months, three of which were conceived and developed entirely by Valeant's internal R&D team. This continues to validate our output driven approach to R&D. Valeant has already successfully launched Jublia (efinaconazole) 10%, Retin-A Micro (tretinoin gel) microsphere 0.08% and Luzu (luliconazole) 1% and we plan to launch Onexton in early 2015."

"Acne is a pervasive disease that, if left unchecked, can have significant impact for patients" said Joshua Zeichner, MD and Director of Cosmetic and Clinical Research, Department of Dermatology, Mount Sinai Hospital. "We encourage people with acne to visit a dermatologist or other healthcare professional for treatment. ONEXTON™ Gel is an effective topical medication, appropriate for patients with a wide range of acne and has a favorable tolerability profile."