Valeant Pharmaceuticals International, Inc.
) has been receiving good news in the last few days.
Last week, Valeant received positive news when the U.S. Food
and Drug Administration (FDA) issued marketing clearance for
Bausch + Lomb's newest frequent replacement silicone hydrogel
Valeant acquired Bausch + Lomb in Aug 2013 to strengthen its
ophthalmology business, which was a miniscule portion of
Valeant's overall portfolio.
Meanwhile, Valeant continues to develop its dermatology
portfolio as well. Valeant received approval for its topical
triazole antifungal solution Jublia (efinaconazole) in
Jublia has been approved for the treatment of mild-to-moderate
onychomycosis, a fungal nail infection.
The approval was based on positive data from two pivotal
studies conducted among 1,655 subjects.
We note that Valeant obtained an exclusive license from Kaken
Pharmaceutical Co., Ltd. to commercialize Jublia in North
America, Central America, South America and the European
However, the approval is still pending in the U.S. Valeant
filed the New Drug Application (NDA) for Jublia in the U.S. in
Jul 2012. In May 2013, the FDA issued a Complete Response Letter
(CRL) to the company regarding its NDA. In the CRL, the FDA has
raised questions relating to Chemistry, Manufacturing and
Controls (CMC) areas of the container closure apparatus.
Valeant expects to address the issues raised by the FDA and
launch the product in 2014 in the U.S. as well.
Valeant currently carries a Zacks Rank #3 (Hold). Right now,
), and look attractive. While Actelion carry a Zacks Rank #1
(Strong Buy), Jazz Pharma and Cempra carry a Zacks Rank #2
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