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O'Conner's Vaporizer in a Bottle

Executive Summary

Company requests a three-month extention of Aug. 14 deadline for filing new data to demonstrate bioequivalence to Richardson-Vicks Vaporub for a Catagory I antitussive claim in the tentative final monograph for cough/cold combinations. Following a Feb. 14 meeting with the agency ("The Pink Sheet" Feb. 29, T&G-9), O'Conner submitted data and a protocol for a proposed in vitro study comparing the vapor concentrations of its Vaporizer in a Bottle and Vicks Vaporub in May. The company said that since it has not received a response to the protodcol from FDA, it is requesting the three month extention.
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PS016084

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