DUBLIN, March 1, 2017 /PRNewswire/ -- Perrigo
Company plc (NYSE; TASE: PRGO) today announced it has received
final approval from the U.S. Food and Drug Administration for its
Abbreviated New Drug Application referencing Eli Lilly and
Company's Axiron® Topical Solution, 30 mg/1.5 mL
(Testosterone Topical Solution, 30 mg/1.5 mL).
Axiron® Topical Solution, 30 mg/1.5 mL is indicated
to treat adult males who have low or no testosterone due to certain
medical conditions. Annual sales for the 12 months ending
January 2017 were approximately
$254 million.
Perrigo's CEO John T. Hendrickson
stated, "This final approval is another example of making long-term
investments in challenging new products. As always, Perrigo is
committed to making quality healthcare more affordable for our
customers and consumers around the world."
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
beginning 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
in the U.S., and receives royalties from 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 in other markets,
including Israel, China, and Latin America. Visit
Perrigo online at (http://www.perrigo.com).
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 future impairment charges, the ability
to achieve its guidance, the ability to timely execute and achieve
the desired benefits of its announced restructuring plan and
initiatives, future asset sales and the timing, amount and cost of
share repurchases. In addition, there can be no assurance that the
Company will be able to file its 2016 Form 10-K within the fifteen
calendar day extension provided by Rule 12b-25, or that the Company
may not identify one or more material weaknesses in its internal
control over financial reporting, need to restate its financial
statements or conclude that investors should no longer rely upon
previously issued financial statements. 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