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news.The Perrigo Company has received approval from the FDA to market over-the-counter orange coated nicotine polacrilex gum USP, 2mg and 4mg.
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The FDA has determined the product to be bioequivalent to the reference listed drug, GlaxoSmithKline’s Nicorette Gum, 2mg (base) and 4mg (base), which is an aid to smoking cessation.
Joseph Papa, Perrigo’s chairman and CEO, said: “This approval of orange-flavored, coated nicotine gum extends our leading store brand position. Our expanded range of smoking cessation products also includes coated mint-flavored gum, coated fruit-flavored gum, uncoated gum and lozenges.”