Caprice-Greystoke foreign efficacy data for Spray-U-Thin deemed "insufficient" by FDA.
This article was originally published in The Tan Sheet
Executive Summary
CAPRICE-GREYSTOKE's SPRAY-U-THIN FOREIGN DATA "INSUFFICIENT" to demonstrate safe and effective use of the oral liquid metered phenylpropanol-amine hydrochloride (PPA) spray in the U.S. for weight control, FDA told the company in a July 25 letter. In response to a clinical test report from the Russian Academy of Medical Sciences submitted to FDA by Caprice-Greystoke on June 26, the agency concluded that the report "contains insufficient data" to "document safe and effective use of this product for weight control" in the U.S.
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