DUBLIN, Oct. 26,
2022 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO)
("Perrigo" or "the Company"), a leading provider of Consumer
Self-Care Products, today announced that it has received
notification that the U.S. Food and Drug Administration (FDA) has
postponed the joint meeting of the Nonprescription Drugs Advisory
Committee and the Obstetrics, Reproductive and Urologic Drugs
Advisory Committee, previously planned for November 18, 2022, to discuss the Company's
application for Opill® once daily oral contraceptive for
OTC use. The rescheduled date for the joint advisory committee
meeting has not yet been determined.
FDA postponed the meeting in order to review additional
information requested related to the
Opill® Rx-to-OTC switch. In a notice received from
the FDA, the Prescription Drug User Fee Act (PDUFA) date
for Opill® has been extended by 90 days. The Company will continue
to work collaboratively with the FDA to ensure a timely and
thorough review.
Earlier this year, Perrigo's affiliate HRA Pharma filed its
application with the FDA for the 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® would 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 postponed FDA
advisory committee meeting described above. While the Company
believes that the FDA advisory committee meeting will be
rescheduled, there can be no assurances that such meeting will
occur, or that it will not be further postponed or 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