DUBLIN, Sept. 12,
2022 /PRNewswire/ -- Perrigo Company plc (NYSE:
PRGO), a leading provider of Consumer Self-Care
Products, today announced that the U.S. Food and Drug
Administration (FDA) has scheduled a joint meeting of the
Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics,
Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) on
November 18, 2022, to review the
Company's application for Opill® daily oral
contraceptive for OTC use.
The Company previously announced its affiliate, HRA Pharma,
filed its application with the FDA for an Rx-to-OTC switch of
Opill®, a progestin-only daily birth control pill
(also referred to as a mini pill or non-estrogen pill). If
approved, Opill® has the potential to be the first ever
daily birth control pill available OTC without a prescription
in the U.S.
About Perrigo
Perrigo Company plc (NYSE; PRGO) is a leading provider of
Consumer Self-Care Products and over-the-counter (OTC)
health and wellness solutions that enhance individual well-being by
empowering consumers to proactively prevent or treat conditions
that can be self-managed. Visit Perrigo online at
www.perrigo.com.
Forward-Looking Statements
Certain statements in this press release relate to future events
and may therefore be considered "forward-looking statements".
Forward-looking statements 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 such statements. Often such factors may be beyond
our control, including risks and uncertainties regarding the
occurrence and timing of regulatory activities, such as the FDA
advisory committee meeting described above. While the Company
believes that the FDA advisory committee meeting has been
scheduled, there can be no assurances that such meeting will occur,
or that it will not be postponed or otherwise rescheduled.
Nor can the outcome of that meeting be predicted. In
particular, there can be no assurance that the FDA will approve the
sale of daily oral contraceptives without a prescription in
the United States. The foregoing
and other important factors, including those discussed under "Risk
Factors" in the Company's Form 10-K for the year ended December 31, 2021, and Form 10-Q for the quarter
ended July 2, 2022, 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