October 01, 2015
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.
September 01, 2015
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.
August 08, 2014
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.