Perrigo obtains FDA OK for nicotine coated mint lozenge OTC

Perrigo has received the Food and Drug Administration’s green light for Nicotine Coated Mint Lozenges, 2 mg and 4 mg over-the-counter.

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.

“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," said Jim Dillard, executive vice president and president of Perrigo’s Consumer Self-Care Americas.

[Read more: Up in smoke: Which smoking-cessation products really help smokers quit?

Nicotine Coated Mint Lozenges, 2 mg and 4 mg, Nicotine Polacrilex Lozenges, help reduce withdrawal symptoms in consumers who are trying to quit smoking, the company said.

[Read more: Kroger pharmacies add smoking cessation services in 2 states]

Retail sales for the national brand equivalent product for the last 12 months ending April 23, 2023, were approximately $20 million, per Circana multi-outlet market data.