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March 14, 2013
16:18 EDTVNDAVanda withdraws Marketing Authorization Application for Fanaptum in EU
Vanda Pharmaceuticals announced that it has withdrawn its Marketing Authorization Application submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use for Fanaptum for the treatment of adult patients with schizophrenia. This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure. Vanda intends to reassess its European regulatory strategy for Fanaptum once the results from the Relapse Prevention Study in Patients with Schizophrenia become available.
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July 17, 2014
08:34 EDTVNDAVanda requests award of $539M in proceedings with Novartis
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July 10, 2014
14:24 EDTVNDAT. Rowe Price reports 10.1% passive stake in Vanda Pharmaceuticals
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