DUBLIN, Jan. 24, 2018 /PRNewswire/ -- Perrigo
Company plc (NYSE; TASE: PRGO) today announced it has received
final approval from the U.S. Food and Drug Administration for the
generic version of Estrace® Cream (estradiol vaginal
cream, USP, 0.01%). This product will be marketed by
Perrigo's partner, Impax Laboratories, Inc. (NASDAQ: IPXL), and is
currently expected to launch in the second quarter of this
year.
Estrace® Cream is indicated in the treatment of
moderate to severe symptoms of vulvar and vaginal atrophy due to
menopause. Market sales of Estrace® Cream over the last
12 months were approximately $457
million, according to IMS Health.
Perrigo Executive Vice President and President Rx
Pharmaceuticals John Wesolowski stated, "This is another example of
our continuing commitment to delivering extended topical products
to patients at more affordable prices."
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 one of the
world's largest manufacturers of over-the-counter ("OTC")
healthcare products and suppliers 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; resolution of uncertain tax positions; the
impact of U.S. tax reform legislation and healthcare policy;
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; 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 be
unable to remediate one or more previously identified material
weaknesses in its internal control over financial reporting.
Furthermore, the Company may incur additional tax liabilities in
respect of 2016 and prior years or be found to have breached
certain provisions of Irish company law in connection with the
Company's restatement of previously filed financial statements,
which may result in 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