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PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR NICOTINE COATED MINT LOZENGE

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DUBLIN, May 16, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for Nicotine Coated Mint Lozenges, 2 mg and 4 mg over-the-counter (OTC).

This product will be marketed under retailer's store brand labels as a comparable offering to Nicorette® Coated Ice Mint Lozenge. Perrigo expects this product to be available for consumers to purchase online and at shelf by early summer 2023.

Perrigo Executive Vice President & President, Consumer Self-Care Americas, Jim Dillard commented, "This approval illustrates our continued ability to develop and bring to market innovative self-care products focused on the preferences and needs of consumers. Congratulations to the team for another important regulatory approval."

Nicotine Coated Mint Lozenges, 2 mg and 4 mg, Nicotine Polacrilex Lozenges, help reduce withdrawal symptoms in consumers who are trying to quit smoking. Retail sales for the national brand equivalent product for the last twelve months ending April 23, 2023, were approximately $20 million based on Circana multi-outlet market data.

Important safety information about Nicotine Coated Mint Lozenges, 2 mg and 4 mg

Before using the product, consumers should read the Nicotine Coated Mint Lozenges, 2 mg and 4 mg drug facts label and corresponding leaflet. 

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. 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 and a top 10 OTC company by revenue in Europe. Visit Perrigo online at www.perrigo.com

Forward-Looking Statements

This press release includes certain "forward-looking statements" within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, such as future product sales and regulatory capabilities, and involve known and unknown risks, uncertainties and other factors—many of which beyond the Company's control—that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, estimates and projections. Interested persons are urged to consult the Company's filings with the United States Securities and Exchange Commission, available at https://investor.perrigo.com/sec-filings, for a discussion of the Company's business and financial condition and certain material trends, risks, uncertainties and other factors relating thereto, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended December 31, 2022.

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SOURCE Perrigo Company plc

Perrigo Company plc

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Pharmaceutical Preparation Manufacturing
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United States of America
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About PRGO

perrigo company plc, a top five global over-the-counter (otc) consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable prices. from its beginnings in 1887 as a packager of generic home remedies, perrigo, headquartered in ireland, has grown to become the world's largest manufacturer of otc products and supplier of infant formulas for the store brand market. the company is also a leading provider of branded otc products, generic extended topical prescription products and receives royalties from multiple sclerosis drug tysabri®. perrigo provides “quality affordable healthcare products®” across a wide variety of product categories and geographies primarily in north america, europe, and australia, as well as other key markets including israel and china. visit perrigo online at (http://www.perrigo.com).