FDA Approves Perrigo’s Nicotine Coated Mint Lozenge

Perrigo Company has received final approval from the FDA 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.

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