FDA Wants Preemptive Lupus Treatment Suit Nixed

Law360, New York (July 23, 2013, 5:44 PM EDT) -- The U.S. Food and Drug Administration on Monday pushed back against Health Science Funding LLC's novel bid for a declaration that labeling on its lupus treatment Prastera complies with FDA requirements for medical foods, arguing that a New Jersey federal court can’t step into the agency’s shoes and apply its regulations.

The FDA asked the court to dismiss Health Science’s suit, which the drug marketer launched in June after FDA officials allegedly warned at an informal meeting that its lupus treatment might not be considered a...
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Case Information

Case Title

HEALTH SCIENCE FUNDING, LLC v. THE UNITED STATES FOOD & DRUG ADMINISTRATION et al


Case Number

2:13-cv-03663

Court

New Jersey

Nature of Suit

Other Statutory Actions

Judge

Claire C. Cecchi

Date Filed

June 13, 2013

Government Agencies

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