OTC oral scopolamine needs additional efficacy data for monograph status -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
ORAL SCOPOLAMINE HYDROBROMIDE ANTIEMETIC EFFICACY DATA INSUFFICIENT to support the effectiveness of the motion sickness ingredient, FDA said in a June 12 letter to Santa Rosa, Calif.-based Sea-Tone, Inc. "Oral scopolamine hydrobromide will not be included in the final monograph for OTC antiemetic products at this time," FDA informed the company.
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