The Perrigo Company has received approval from the US Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polarcrilex lozenges, 2 mg and 4 mg.

The product will be marketed under store brand labels and is equivalent to GlaxoSmithKline's Commit lozenges. The product is indicated as an aid to smoking cessation. Retail sales for Commit lozenges were approximately $100 million in calendar 2005.

Perrigo was the first applicant to file a complete abbreviated new drug application (ANDA) with a Paragraph IV certification and has been granted 180 days of generic market exclusivity. First shipments are expected within 30 days, claims the company release.

The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market.