Perrigo FDA Approved To Market Nicotine Gum
The Perrigo Company has received approval from FDA to market over-the-counter (OTC) 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, 2 mg (base) and 4 mg (base), which is an aid to smoking cessation.
"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," said Joseph C. Papa, Perrigo's Chairman and CEO.
The overall market for OTC nicotine gum and lozenge products is estimated at approximately $750 million annually at all retail outlets.