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.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
People In Brief
Perrigo promotes in pricing, planning
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: