Perrigo to Launch Mini Nicotine Lozenges

The drug firm has received the go-ahead from the FDA to market the OTC smoking-cessation product.

The Perrigo Company today announced that it has received approval from the U.S. 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.

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.

Source: Perrigo Co.
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