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Nicotine "lollipop" ANDA suitability petition

Executive Summary

Altana's Savage Labs division requests permission to file an ANDA for its Nic Stics (nicotine polacrilex) 2 mg "lollipop" in a recent petition. The product differs from the listed drug, Marion Merrell Dow's Nicorette chewing gum, in dosage form. The petition says that Nic Stics is identical in strength and route of administration as Nicorette but has the advantage of "satisfying the 'hand-to-mouth habit'".
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PS023683

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