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IMMEDIATE-RELEASE PHENYLPROPANOLAMINE STATUS AT FDA QUESTIONED

This article was originally published in The Tan Sheet

Executive Summary

IMMEDIATE-RELEASE PHENYLPROPANOLAMINE STATUS AT FDA QUESTIONED by Caprice-Greystoke in an Aug. 1 citizen petition that responds to a May 20 letter from FDA's OTC Monograph Staff Director William Gilbertson, PharmD, to the Nonprescription Drug Manufacturers Association. Gilbertson informed NDMA that FDA currently considers extended-release phenylpropanolamine to have Category I status for efficacy as an OTC weight-control product but that "existing data are inadequate to support immediate-release doses of 25-50 mg PPA" ("The Tan Sheet" May 30, p. 1).

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