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Valeant's Onexton Gel Gets FDA Approval for Acne

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Valeant Pharmaceuticals International, Inc.’s (VRX) shares gained 1.5% immediately on news that the company’s Onexton Gel, 1.2%/3.75% has been approved by the FDA for the once-daily treatment of patients (12 years and above) suffering from acne vulgaris (including non-inflammatory comedonal and inflammatory acne). Although shares were slightly down in the subsequent trading session, overall, shares have been up 2% since the announcement.

According to Valeant, 40 million – 50 million people in the U.S. suffer from acne vulgaris.

Onexton is the first and only fixed combination of clindamycin phosphate (1.2%) and benzoyl peroxide (3.75%) to receive FDA approval for the once-daily treatment of non-inflammatory comedonal and inflammatory acne.

We note that Onexton is the fourth product in Valeant’s dermatology portfolio to obtain FDA approval over the last 12 months following Jublia 10%, Retin-A Micro microsphere 0.08% and Luzu 1%. Valeant intends to launch Onexton in early 2015.

GlaxoSmithKline’s (GSK) Veltin Gel is also approved for the topical treatment of acne vulgaris.

Meanwhile, Valeant is working towards the development of its ophthalmology pipeline. It intends to file a new drug application (:NDA) for Vesneo (reduction of intraocular pressure in patients with glaucoma or ocular hypertension) in the first half and Lotemax next generation (inflammation and pain following cataract surgery) in the second half of 2015. Additionally, Valeant plans to file an NDA for brimonidine (eye whitener) in the first quarter of 2015.

Valeant carries a Zacks Rank #1 (Strong Buy). Some other well-placed stocks in the health care sector are Sucampo Pharmaceuticals, Inc. (SCMP), Impax Laboratories Inc. (IPXL) and Alexion Pharmaceuticals, Inc. (ALXN). While Sucampo and Impax carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).

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