FDA approves OTC smoking cessation lozenges..

July 13, 2009 - The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex lozenge USP, 2 mg and 4 mg in cherry and cinnamon flavors.

The new products will be marketed under store brand labels and are comparable to GlaxoSmithKline's Commit(R) lozenge, which is an aid to smoking cessation.

Perrigo's Chairman and CEO Joseph C. Papa stated, "These two approvals expand our exclusive position in the store brand nicotine lozenge category. The expanded range of smoking cessation products also includes coated mint and Fruit Chill(TM) flavored gum, uncoated gum and lozenges." The smoking cessation category is selling at an annual rate estimated at approximately $1 billion at all retail outlets. We expect to begin shipments in the near future.

Reference: Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges, SOURCE Perrigo Company, prnewswire.com, 7/13/2009.