The Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and AP, has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor).
This ANDA approval represents the first approval for mini lozenge products that will be targeted for the store brand market. The mint flavored mini lozenge will be marketed under retailer and wholesalers' store, or own brand labels and is comparable to GlaxoSmithKline's Nicorette Mini Lozenge. The product 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," said Joseph C. Papa, Perrigo's chairman, president and chief executive officer.
Nicorette Mini Lozenge is selling at an annual rate estimated at over $30 million at all retail outlets. The product is expected to begin shipping in the next 90 days.