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CAPRICE-GREYSTOKE's SPRAY-U-THIN CONSIDERED "NEW DRUG,"

This article was originally published in The Tan Sheet

Executive Summary

CAPRICE-GREYSTOKE's SPRAY-U-THIN CONSIDERED "NEW DRUG," FDA told the Vista, Calif.-based company in a Dec. 22, 1993 letter. FDA said it considers the diet aid product to be "a new drug based on the dosage and the method and duration of administration of the active ingredient, even though the active ingredient is not new and is available in a variety of dosage forms." The active ingredient of Spray-U-Thin, phenylpropanolamine, is administered through a pump spray.
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