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EISAI INC. v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:14-cv-01346
Court:
Nature of Suit:
Administrative Procedure Act/Review or Appeal of Agency Decision
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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October 01, 2015
Eisai Loses Bid For Longer Exclusivity In FDA Delay Fight
Eisai Inc. lost its bid to require the U.S. Food and Drug Administration to extend the market exclusivity periods for two of its drugs when a Washington, D.C., federal judge found Wednesday he had to defer to the agency's own interpretation of its standards for drug marketing.
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September 01, 2015
Eisai Says FDA Wrongly Denied Drug Exclusivity Extension
Eisai Inc. told a Washington, D.C., federal judge Tuesday that the U.S. Food and Drug Administration should be required to extend market exclusivity periods for an epilepsy drug and a weight-loss drug, saying the regulator had wrongly failed to take into account delays caused by required controlled substance reviews.
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August 08, 2014
Eisai Sues FDA To Reclaim Lost Exclusivity For 2 Drugs
Eisai Inc. on Friday sued the U.S. Food and Drug Administration in D.C. federal court for refusing to adjust the approval dates of two prescription drugs to reflect the actual dates on which they were allowed to be sold, accusing regulators of reducing its market exclusivity by arbitrarily declining to be flexible.