Oral solution NRT
This article was originally published in The Tan Sheet
Executive Summary
FDA denies Nico Worldwide's petition to file ANDAs for its nicotine oral solution, citing a need for human clinical trials to determine safety and efficacy. The Pacific Palisades, Calif.-based firm compared its generic nicotine polacrilex 2 mg and 4 mg base per 240 mL oral solutions to GlaxoSmithKline's Commit nicotine lozenges in the ANDA suitability petitions (1"The Tan Sheet" Aug. 2, 2004, In Brief). The oral solution is "unlikely to be bioequivalent to the approved lozenge" due to the different sites of absorption for the GSK and Nico Worldwide products, FDA states...