Perrigo gets OK from FDA to market nicotine lozenge

News

Hannah Blake

pharmaphorum

The US FDA has approved Perrigo’s Abbreviated New Drug Applications to market its over-the-counter nicotine lozenge. The mint-flavoured nicotine polacrilex mini lozenge USP, 2 mg and 4mg will be marketed under retailer and wholesalers’ store, or own brand labels. This is the first approval for mini lozenge products that are targeted for the store brand market, according to Perrigo.

"This approval strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and lozenges."

Joseph C. Papa, Chief Executive of Perrigo.

The product is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Perrigo’s lozenges will go up against GlaxoSmithKline's Nicorette Mini Lozenge.

Perrigo has seen strong growth (both top- and bottom- line) over the past year, driven by rising demand for affordable medicines.

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