DUBLIN, Sept. 21, 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
AB rated Abbreviated New Drug Application referencing
Exalgo® 32mg extended release tablets (hydromorphone
HCl). The company anticipates launching this product by the end of
September 2017.
Exalgo® 32mg extended release tablets (hydromorphone
HCl) is an opioid agonist indicated for the management of moderate
to severe pain in opioid tolerant patients requiring continuous,
around-the-clock opioid analgesia for an extended period of time.
Annual market sales for the brand and generic equivalents of
Exalgo® 32mg extended release tablets for the 12 months
ended July 2017 were approximately
$35 million.
Perrigo Executive Vice President and President Rx
Pharmaceuticals John Wesolowski stated, "This final approval
exemplifies Perrigo's commitment to developing quality, high value
alternatives in important treatment categories. The Rx team
continues to leverage our development capabilities to deliver
Quality Affordable Healthcare Products® to
customers, consumers and families around the world."
About Perrigo
Perrigo Company plc, a leading global
healthcare company, delivers value to its customers and consumers
by providing Quality Affordable Healthcare
Products®. Founded in 1887 as a packager of home
remedies, Perrigo has built a unique business model that is best
described as the convergence of a fast-moving consumer goods
company, a high-quality pharmaceutical manufacturing organization
and a world-class supply chain network. Perrigo is the world's
largest manufacturer of over-the-counter ("OTC") healthcare
products and supplier of infant formulas for the store brand
market. The Company also is a leading provider of branded OTC
products throughout Europe and the U.S., as well as a
leading producer of "extended topical" prescription drugs. Perrigo,
headquartered in Ireland, sells its products primarily
in North America and Europe, as well as in other
markets, including Australia,
Israel and China. 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: the timing, amount and cost of any share repurchases;
future impairment charges; the success of management transition;
customer acceptance of new products; competition from other
industry participants, some of whom have greater marketing
resources or larger market shares in certain product categories
than the Company does; pricing pressures from customers and
consumers; potential third-party claims and litigation, including
litigation relating to the Company's restatement of
previously-filed financial information; potential impacts of
ongoing or future government investigations and regulatory
initiatives; general economic conditions; fluctuations in currency
exchange rates and interest rates; the consummation of announced
acquisitions or dispositions, and the Company's ability to realize
the desired benefits thereof; the Company's ability to achieve its
guidance; and the Company's ability to execute and achieve the
desired benefits of announced cost-reduction efforts and other
initiatives. In addition, the Company may identify and be
unable to remediate one or more material weaknesses in its internal
control over financial reporting. Furthermore, the Company and/or
its subsidiaries may incur additional tax liabilities in respect of
2016 and prior years as a result of any restatement or may be found
to have breached certain provisions of Irish company legislation in
respect of prior financial statements and if so may incur
additional expenses and penalties. These and other important
factors, including those discussed under "Risk Factors" in the
Company's Form 10-K for the year ended December 31, 2016, as
well as the Company's subsequent filings with the United States
Securities and Exchange Commission, 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