FDAnews Drug Daily Bulletin

FDA APPROVES PERRIGO'S SMOKING-CESSATION GUM

June 27, 2006
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Perrigo has received approval from the FDA to market OTC coated nicotine polacrilex gum in 2-mg and 4-mg dosages. The company said it expects to begin shipping the gum in the fourth quarter of 2006.

The product will be marketed under store brand labels and is comparable to GlaxoSmithKline's Nicorette Fresh Mint coated gum, which a smoking-cessation aid, said Perrigo.

Retail sales for Nicorette gum were approximately $100 million in the past 12 months.