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Public Citizen v. Food and Drug Administration (propoxyphene)

Topic(s): Health and Safety Regulations
Date Of Involvement: 06/19/2008

Related Documents:
Description:

This case was filed under the Food, Drug, and Cosmetic Act (FDCA) and the Administrative Procedure Act (APA) to compel the FDA to act on Public Citizen's petition seeking a phased withdrawal of the painkiller propoxyphene (Darvon) and all propoxyphene-containing products such as Darvocet. We allege that FDA's failure to act on Public Citizen's petition constitutes agency action unlawfully withheld or unreasonably delayed, and we seek an order directing FDA to act on the petition.

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