Executive SummaryCompanies with combination drug products containing hydrocortisone acetate and pramoxine hydrochloride have until Oct. 31 to file data and information in support of hearing requests concerning the withdrawal of such products from the market. FDA granted an extension to the original Aug. 31 filing date, set in a July 1 Federal Register notice, after Parke-Davis, Ferndale Labs, Copley Pharmaceutical, and Reed and Carnrick appealed for an end of November filing date.
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