FDA gives Perrigo approval for OTC nicotine gum

ALLEGAN, Mich. Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market over-the-counter Nicotine Polacrilex Gum USP, 2 mg (base) and 4 mg (base) (Orange, Coated).

The FDA has determined the product to be bioequivalent to the reference listed drug, GlaxoSmithKline’s Nicorette Gum, which is an aid to smoking cessation.

“This approval of orange-flavored, coated nicotine gum extends our leading store brand position,” stated Joe Papa, Perrigo chairman and chief executive officer. “Our expanded range of smoking cessation products also includes coated mint-flavored gum, coated fruit-flavored gum, uncoated gum and lozenges.”

The overall market for OTC nicotine gum and lozenge products is estimated at approximately $750 million annually at all retail outlets, Perrigo reported.