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Antitussive Combo With Wick Delivery Needs Two Clinical Studies – FDA

This article was originally published in The Tan Sheet

Executive Summary

Two clinical studies are needed to support cough/cold monograph status for a menthol/camphor/eucalyptus oil combination product with a wick delivery system, FDA stated at a recent "feedback" meeting on Lil' Drug Store's antitussive Vaporizer in a Bottle

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Lil’ Drug Store backs down

Cedar Rapids-based firm will not conduct requested clinical studies for its Vaporizer in a Bottle product to gain inclusion for the OTC cough/cold monograph. "We found that we could not complete the research studies in a format consistent with FDA requirements, at a price that justified the investment of capital in the brand with an uncertain study outcome," the firm says in a June letter to the agency. FDA told Lil' Drug Store at a November "feedback" meeting that two clinical studies would be necessary to secure monograph status (1"The Tan Sheet" Nov. 3, 2003, p. 9)...

Lil’ Drug Store backs down

Cedar Rapids-based firm will not conduct requested clinical studies for its Vaporizer in a Bottle product to gain inclusion for the OTC cough/cold monograph. "We found that we could not complete the research studies in a format consistent with FDA requirements, at a price that justified the investment of capital in the brand with an uncertain study outcome," the firm says in a June letter to the agency. FDA told Lil' Drug Store at a November "feedback" meeting that two clinical studies would be necessary to secure monograph status (1"The Tan Sheet" Nov. 3, 2003, p. 9)...

Lil’ Drug Store backs down

Cedar Rapids-based firm will not conduct requested clinical studies for its Vaporizer in a Bottle product to gain inclusion for the OTC cough/cold monograph. "We found that we could not complete the research studies in a format consistent with FDA requirements, at a price that justified the investment of capital in the brand with an uncertain study outcome," the firm says in a June letter to the agency. FDA told Lil' Drug Store at a November "feedback" meeting that two clinical studies would be necessary to secure monograph status (1"The Tan Sheet" Nov. 3, 2003, p. 9)...

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