Lil’ Drug Store backs down
This article was originally published in The Tan Sheet
Executive Summary
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)...