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Hydrocortisone 1%

Executive Summary

P-A submits U.K. Dept. of Health and Social Security data on OTC use of 1% hydrocortisone to supplement its Rx-to-OTC petition. FDA requested foreign data on 1% hydrocortisone in a July 12 meeting that followed the association's May 12 petition for the switch. P-A noted that 1% hydrocortisone is also marketed OTC in Sweden, Denmark and Norway, and that a Rx-to-OTC petition is under review in W. Germany.

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