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news.Perrigo Company has received approval from the FDA to market its generic version of Commit, GlaxoSmithKline's over-the-counter smoking cessation medication.
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The product, which has approval for 2mg and 4mg dosages, will be marketed under the retailers own brand labels. Retail sales for Commit lozenges were approximately $100 million in 2005 according to the company.
Since Perrigo was the first to file a complete abbreviated new drug application for a generic version of the drug, the company has been granted 180 days of generic market exclusivity. The company is expected to begin shipping of the drug within 30 days.
Earlier this month, Perrigo was also given permission by the FDA to market its generic version of Taro Pharmaceutical’s Topicort gel, which is indicated for the relief of inflammatory skin conditions, and has US sales of approximately $4 million.