DUBLIN, Feb. 7, 2017 /PRNewswire/ -- Perrigo Company plc
(NYSE; TASE: PRGO) announced that it has filed an Abbreviated New
Drug Application (ANDA) with the U.S. Food and Drug Administration
(FDA) for clindamycin, benzoyl peroxide topical gel, the generic
version of Onexton® gel (clindamycin phosphate 1.2% and benzoyl
peroxide 3.75%). Perrigo has notified Valeant Pharmaceuticals North
America LLC and Dow Pharmaceutical Sciences, Inc. (Valeant) the
owner of both the New Drug Application and patents listed in FDA's
Orange Book, of its filing.
On February 3, 2017, Valeant filed
suit in the United States District Court for the District of
New Jersey alleging patent
infringement. This action formally initiates the litigation process
under the Hatch-Waxman Act.
Onexton® gel (clindamycin phosphate 1.2% and benzoyl peroxide
3.75%) is a prescription medicine indicated for the once-daily
treatment of comedonal (non-inflammatory) and inflammatory acne.
Branded sales for the 12 months ending December 2016 were approximately $139 million.
Perrigo's CEO John T. Hendrickson
stated, "This filing demonstrates Perrigo's commitment to providing
Quality Affordable Healthcare Products® to our
customers and consumers around the world. The Rx team continues to
invest in the development of important products that drive savings
for patients and the healthcare
system."
About Perrigo
Perrigo Company plc, a leading global over-the-counter ("OTC")
consumer goods and pharmaceutical company, offers patients and
customers high quality products at affordable prices. From its
beginnings in 1887 as a packager of home remedies, Perrigo,
headquartered in Ireland, has
grown to become the world's largest manufacturer of OTC healthcare
products and supplier of infant formulas for the store brand
market. The Company is also a leading provider of generic extended
topical prescription products and receives royalties from the sales
of the multiple sclerosis drug Tysabri®. Perrigo provides Quality
Affordable Healthcare Products® across a wide variety of product
categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including
Israel, China and Latin
America.
Forward-Looking Statements
Certain statements in this press release are "forward-looking
statements." These statements relate to future events or the
Company's future financial performance and involve known and
unknown risks, uncertainties and other factors that may cause the
actual results, levels of activity, performance or achievements of
the Company or its industry to be materially different from those
expressed or implied by any forward-looking statements. In some
cases, forward-looking statements can be identified by terminology
such as "may," "will," "could," "would," "should," "expect,"
"plan," "anticipate," "intend," "believe," "estimate," "predict,"
"potential" or the negative of those terms or other comparable
terminology. The Company has based these forward-looking statements
on its current expectations, assumptions, estimates and
projections. While the Company believes these expectations,
assumptions, estimates and projections are reasonable, such
forward-looking statements are only predictions and involve known
and unknown risks and uncertainties, many of which are beyond the
Company's control, including the timing, amount and cost of share
repurchases, future impairment charges, the ability to achieve its
guidance and the ability to execute and achieve the desired
benefits of announced initiatives. These and other important
factors, including those discussed under "Risk Factors" in the
Company's Form 10-KT for the six-month period ended December 31, 2015, as well as the Company's
subsequent filings with the SEC, may cause actual results,
performance or achievements to differ materially from those
expressed or implied by these forward-looking statements. The
forward-looking statements in this press release are made only as
of the date hereof, and unless otherwise required by applicable
securities laws, the Company disclaims any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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SOURCE Perrigo Company plc