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Oral solution NRT?

This article was originally published in The Tan Sheet

Executive Summary

Nicoworldwide is pursuing FDA approval of generic nicotine polacrilex, bitartrate and base solutions equivalent to GlaxoSmithKline's Commit nicotine lozenge. In three separate ANDA suitability petitions submitted to FDA in early July, the Pacific Palisades, Calif.-based firm requests permission to file ANDAs for the three nicotine drugs, all in a 2 mg and 4 mg base per 240 mL oral solution. Although the proposed products would feature a different dosage form than the GSK lozenge, they would "not differ from the listed drug in strength (base form) or route of delivery," Nicoworldwide says...

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Oral solution NRT





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