FDA Sued Over Delay On Pfizer Alzheimer's Drug Decision

Law360, New York (September 5, 2012, 3:36 PM EDT) -- A consumer advocacy group sued the U.S. Food and Drug Administration Wednesday in Washington federal court, in a bid to force the agency to decide on its petition to pull a Pfizer Inc. Alzheimer's drug from the market over efficacy and safety concerns.

Public Citizen Inc. filed a petition with the FDA in May 2011 that contended a 23-milligram dose of Aricept, manufactured by Eisai Co. Ltd. and marketed by Pfizer, failed to meet agency-required efficacy criteria for dementia drugs. The dose also demonstrated significantly more...
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Case Information

Case Title

PUBLIC CITIZEN, INC. v. FOOD AND DRUG ADMINISTRATION


Case Number

1:12-cv-01461

Court

District Of Columbia

Nature of Suit

Administrative Procedure Act/Review or Appeal of Agency Decision

Judge

Colleen Kollar-Kotelly

Date Filed

September 5, 2012

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Government Agencies

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