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: FDA’s 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: FDA’s 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:
|