ALLEGAN, Mich. — Perrigo on Wednesday announced that it has received approval from the Food and Drug Administration for its abbreviated new drug applications to market over-the-counter nicotine polacrilex mini lozenge USP in both 2-mg and 4-mg strengths.
The mint-flavored mini lozenge is comparable with GlaxoSmithKline's Nicorette Mini Lozenge and is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.
"This approval strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and lozenges," Joseph Papa, Perrigo's chairman, president and CEO Joseph Papa said.
Nicorette Mini Lozenge is selling at an annual rate estimated at more than $30 million across all retail outlets. The product is expected to begin shipping in the next 90 days, Perrigo reported.