PERRIGO ANNOUNCES JOINT FDA ADVISORY COMMITTEE TO REVIEW OPILL® DAILY ORAL CONTRACEPTIVE FOR OTC (OTC) USE
DUBLIN, September 12, 2022 /PRNewswire/ — Perrigo Company plc (NYSE: PRGO), a leading provider of consumer self-care products, announced today that the US 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). November 18, 2022to review the company’s application for Opill® daily oral contraceptive for over-the-counter use.
The company previously announced that its subsidiary HRA Pharma has submitted an application to the FDA for an Rx-to-OTC switch from Opill®, a progestin-only pill for daily contraception (also known as the minipill or non-estrogen pill). If approved, Opill® has the potential to be the first birth control pill available in the US without a prescription
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 self-manageable conditions. Visit Perrigo online at www.perrigo.com.
Certain statements in this press release address future events and may be considered “forward-looking statements.” Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s or its industry’s actual results, activities, performance or achievements to differ materially from those expressed or implied by such statements. Often such factors are beyond our control, including risks and uncertainties related to the occurrence and timing of regulatory activity, such as B. the FDA Advisory Committee meeting described above. Although the Company believes that the FDA Advisory Committee meeting has been scheduled, there can be no assurance that such a meeting will take place or that it will not be postponed or otherwise scheduled. The outcome of this meeting cannot be predicted either. In particular, there can be no guarantee that the FDA will approve the sale of daily oral contraceptives in The United States. The foregoing and other important factors, including those discussed under “Risk Factors” on the Company’s Form 10-K for the current fiscal year December 31, 2021and Form 10-Q for the current quarter July 2, 2022, and the Company’s subsequent filings with the United States Securities and Exchange Commission, could 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 speak only as of the date of this release and, except as otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether new or based on future events or other.
SOURCE Perrigo Company plc