46 documents

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07:00 , May 11, 2015 |  BC Week In Review  |  Company News

Eisai, Glenmark neurology news

Eisai and Glenmark settled patent litigation relating to Eisai’s Banzel rufinamide for seizures. Under the settlement terms, Glenmark will be permitted to market a generic version of Banzel in the U.S. on May 30,...
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07:00 , Mar 16, 2015 |  BC Week In Review  |  Clinical News

Banzel rufinamide regulatory update

FDA approved an sNDA from Eisai for Banzel rufinamide as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ages 1-4. Eisai markets the triazole derivative in the U.S. as Banzel and...
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07:00 , Oct 20, 2014 |  BC Week In Review  |  Clinical News

Banzel rufinamide regulatory update

FDA accepted and granted Priority Review to an sNDA from Eisai for Banzel rufinamide as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ages 1-3 years. The PDUFA date is Feb....
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01:45 , Oct 15, 2014 |  BC Extra  |  Company News

Priority Reviews for Eisai's lenvatinib and rufinamide

Eisai Co. Ltd. (Tokyo:4523) said FDA accepted for filing and granted Priority Review to an NDA for lenvatinib ( E7080) and an sNDA for rufinamide ( E2080). Eisai is seeking approval of lenvatinib to treat...
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08:00 , Jan 6, 2014 |  BC Week In Review  |  Company News

Eisai sales and marketing update

On Jan. 2, Eisai said it would launch Fycompa perampanel in the U.S. on Jan. 6 as adjunct treatment for partial onset seizures in patients with epilepsy ages 12 years and older. The wholesale...
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07:00 , Apr 8, 2013 |  BC Week In Review  |  Company News

Eisai sales and marketing update

Eisai launched NerBloc botulinum toxin type B intramuscular injection 2,500 unit in Japan to treat cervical dystonia. Each vial has a National Health Insurance (NHI) list price of ¥28,902 ($307). In 2000, Eisai received Japanese...
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08:00 , Jan 7, 2013 |  BC Week In Review  |  Company News

Eisai sales and marketing update

Eisai launched Inovelon rufinamide oral suspension in Spain for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years of age and older. Eisai markets the triazole derivative in the...
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07:00 , Sep 3, 2012 |  BC Week In Review  |  Clinical News

Inovelon rufinamide regulatory update

Eisai submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for rufinamide as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS). Eisai markets the triazole derivative for patients >4...
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00:19 , Aug 31, 2012 |  BC Extra  |  Company News

Eisai seeks approval of rufinamide in Japan

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for rufinamide as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS). Eisai markets the triazole...
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07:00 , Jul 16, 2012 |  BC Week In Review  |  Clinical News

Inovelon rufinamide regulatory update

Swissmedic approved Inovelon rufinamide orange-flavored oral suspension as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients >4 years. Eisai already markets the triazole derivative in Europe. Rufinamide is marketed in the...
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