PERRIGO ANNOUNCES JOINT FDA ADVISORY COMMITTEE TO REVIEW OPILL® DAILY ORAL CONTRACEPTIVE FOR OVER-THE-COUNTER (OTC) USE

Rhea-AI Summary

Perrigo Company plc (NYSE: PRGO) announced that the FDA will hold a joint meeting on November 18, 2022, to review its application for Opill^®, a daily oral contraceptive, for over-the-counter (OTC) use. This could mark Opill^® as the first daily birth control pill available OTC in the U.S. The application was filed by Perrigo's affiliate, HRA Pharma. However, the outcome of the FDA's review remains uncertain, and there are risks associated with regulatory approval.

Positive

• Potential first OTC daily birth control pill, enhancing market position.
• Review meeting scheduled with the FDA may expedite product launch.

Negative

• Outcome of the FDA meeting is uncertain, posing risks.
• No guarantees on FDA approval for OTC sale.

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

FAQ

What is the FDA meeting about for PRGO scheduled on November 18, 2022?

The FDA meeting will review Perrigo's application for Opill® as an over-the-counter daily oral contraceptive.

What is Opill® and why is it significant for Perrigo (PRGO)?

Opill® is a progestin-only daily birth control pill that, if approved, will be the first daily contraceptive available OTC in the U.S.

What risks does Perrigo (PRGO) face regarding the FDA's decision on Opill®?

Perrigo faces uncertainty regarding the FDA's approval outcome and potential delays in the review process.

How could FDA approval impact Perrigo's stock (PRGO)?

FDA approval could significantly enhance Perrigo's market presence and drive revenue growth from Opill®.