Regulatory History of OTC Phenylpropanolamine Hydrochloride (PPA)

10/30/00


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Table of Contents

Regulatory History of OTC Phenylpropanolamine Hydrochloride (PPA)

1972: The OTC Drug Review

Classification Categories

Marketing Status During OTC Review

OTC PPA Rulemakings:

Status of PPA in the OTC Review

1982 Weight Control ANPR

Nasal Decongestant Rulemaking

1990: FDAs Conclusions Regarding the Blood Pressure (BP) Studies:

House of Representatives Hearing on Dieting, PPA, and Federal Research

1991: Public Meeting on the Safety and Effectiveness of PPA

1994: FDAs Conclusion on Effectiveness

1991: FDA Reviews Spontaneous Reporting System (SRS) Cases

Difficulties In Assessing PPA Safety:

1992: Epidemiologist Consultants Review the Stroke Data

In 1992, FDA Concluded:

Yale Hemorrhagic Stroke Project (HSP)

1996: FDA Proposed Stronger Label Warnings For All OTC PPA Products

October 19, 2000 Agenda:

Author: CDER USER