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news.The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug applications (ANDA) for over-the-counter (OTC) nicotine polacrilex mini lozenge.
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The OTC smoking cessation lozenge, which is mint flavored, is available in different doses including 2 mg and 4 mg.
The product is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.
The company said its mint flavored mini lozenge, which will be marketed under retailer and wholesalers’ store or own brand labels, is comparable to GlaxoSmithKline’s Nicorette Mini Lozenge.
Perrigo chairman, president and chief executive officer Joseph Papa said, "This approval strengthens Perrigo’s leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and lozenges."