PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR OTC USE OF NASONEX® 24HR ALLERGY

Rhea-AI Summary

Perrigo Company plc (NYSE: PRGO) has received final FDA approval for the over-the-counter use of Nasonex® 24HR Allergy (mometasone furoate monohydrate 50mcg). This marks the company’s first Rx-to-OTC switch, set to enhance its product offerings and strengthen its market presence. Perrigo plans to launch Nasonex® later this year, aiming to provide consumers with quality self-care options. This approval underscores Perrigo's commitment to innovation in self-care products, potentially increasing revenue through expanded market access.

Positive

• FDA approval for OTC use of Nasonex® 24HR Allergy positions Perrigo to enhance market presence.
• First Rx-to-OTC switch for Perrigo, indicating innovation success.
• Expected launch later this year expands Perrigo's product offerings.

Negative

• None.

DUBLIN, March 17, 2022 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Quality, Affordable Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for the over-the-counter use of Nasonex® 24HR Allergy (mometasone furoate monohydrate 50mcg). This approval marks the first branded Rx-to-OTC switch for the Company and paves the way for Nasonex® to enter the OTC marketplace. Perrigo expects to begin offering Nasonex® 24HR Allergy later this year.

Perrigo Executive Vice President & President, Consumer Self-Care Americas, Jim Dillard commented, "This first Rx-to-OTC switch for Nasonex® represents our continued focus on providing quality, affordable self-care products that consumers know and trust. It also epitomizes the strength of our internal innovation, R&D and regulatory capabilities. Successfully bringing Rx-to-OTC switches to market expands offerings available to consumers, enhances offerings for our retail partners and continues to differentiate Perrigo in the marketplace."

*NASONEX® is a registered trademark of Organon LLC and is used by Perrigo Company plc and its affiliates under license.

About Perrigo 

Perrigo Company plc (NYSE: PRGO) is a leading provider of Quality, Affordable 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. Led by its consumer self-care strategy, Perrigo is the largest store brand OTC player in the U.S. in the categories in which it competes through more than 9,000 SKUs under customer 'own brand' labels. Additionally, Perrigo is a Top 10 OTC company by revenue in Europe, where it markets more than 200 branded OTC products throughout 28 countries. Visit Perrigo online at 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," "forecast," "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 effect of the coronavirus (COVID-19) pandemic and its variants and the associated supply chain impacts on the Company's business; general economic, credit, and market conditions; future impairment charges; 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; resolution of uncertain tax positions, including the Company's appeal of the draft and final Notices of Proposed Assessment ("NOPAs") issued by the U.S. Internal Revenue Service and the impact that an adverse result in any such proceedings would have on operating results, cash flows, and liquidity; pending and potential third-party claims and litigation, including litigation relating to the Company's restatement of previously-filed financial information and litigation relating to uncertain tax positions, including the NOPAs; potential impacts of ongoing or future government investigations and regulatory initiatives; potential costs and reputational impact of product recalls or sales halts; the impact of tax reform legislation and healthcare policy; the timing, amount and cost of any share repurchases; fluctuations in currency exchange rates and interest rates; the Company's ability to achieve the benefits expected from the sale of its Rx business and the risk that potential costs or liabilities incurred or retained in connection with that transaction may exceed the Company's estimates or adversely affect the Company's business or operations; the consummation and success of the proposed acquisition of HRA Pharma and the ability to achieve the expected benefits thereof, including the risk that the parties fail to obtain the required regulatory approvals or to fulfill the other conditions to closing on the expected timeframe or at all, the occurrence of any other event, change or circumstance that could delay the transaction or result in the termination of the securities sale agreement or the risks that the Company's synergy estimates are inaccurate or that the Company faces higher than anticipated integration or other costs in connection with the proposed acquisition; the consummation and success of other announced and unannounced 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 strategic and other initiatives. An adverse result with respect to the Company's appeal of any material outstanding tax assessments or pending litigation, including securities or drug pricing matters, could ultimately require the use of corporate assets to pay such assessments, damages from third-party claims, and related interest and/or penalties, and any such use of corporate assets would limit the assets available for other corporate purposes. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2020, 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 significance of Perrigo's FDA approval for Nasonex® 24HR Allergy?

The FDA approval allows Perrigo to market Nasonex® as an over-the-counter product, marking a key strategic shift and enhancing its product lineup.

When will Nasonex® 24HR Allergy be available for consumers?

Perrigo plans to launch Nasonex® 24HR Allergy later this year following FDA approval.

How does the Rx-to-OTC switch affect Perrigo's market positioning?

The switch allows Perrigo to compete more effectively in the self-care market and expands accessibility for consumers, potentially increasing sales.

What is the active ingredient in Nasonex® 24HR Allergy?

The active ingredient in Nasonex® 24HR Allergy is mometasone furoate monohydrate 50mcg.

What are the potential benefits of Nasonex® 24HR Allergy for consumers?

Nasonex® 24HR Allergy provides relief from allergy symptoms, offering consumers a trusted self-care option without the need for a prescription.