Valeant Receives FDA's Clearance for Restylane - Analyst Blog

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Valeant Pharmaceuticals International, Inc. ( VRX ) announced that the FDA issued a marketing clearance for Restylane Silk Injectable Gel with 0.3% Lidocaine.

Restylane Silk Injectable Gel is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.

Valeant had conducted a clinical study (n=221) on Restylane to evaluate the safety and effectiveness of injections among females with light and dark skin to enhance lip fullness and to improve wrinkles around the lips.


As observed in the study data, 98% of subjects reported improvement in their lip fullness 14 days after injection and 76% of the subjects still had lip improvement 6 months after their injection.

We remind investors that in May 2014, Valeant entered into an agreement with Nestle S.A to sell its rights of Restylane, Perlane, Emervel, Sculptra, and Dysport for $1.4 billion in cash.

Valeant had acquired rights to aesthetics products such as Dysport, Perlane, and Restylan through its acquisition of Medicis in Dec 2012.

Earlier in the month, the FDA approved Valeant's New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution) for the treatment of onychomycosis of the toenails.

Meanwhile, Valeant is engaged in a patent infringement suit with Allergan, Inc . ( AGN ) for Restylane and Perlane dermal filler products. Allergan has accused Valeant of infringing some of its patents in the U.S.

We note that Allergan recently rejected the revised acquisition offer by Valeant and Pershing Square Capital Management.

Valeant currently has a Rank #3 (Hold). Investors looking for better-ranked stocks in the healthcare sector may consider companies like Gilead Sciences ( GILD ) and Forest Laboratories Inc. ( FRX ). While Gilead Sciences carries a Zacks Rank #1 (Strong Buy), Forest Labs is a Zacks Rank #2 (Buy).


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: FRX , AGN , GILD

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