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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Vanda Pharmaceuticals announced that it has withdrawn its Marketing Authorization Application submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use for Fanaptum for the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.
News For VNDA From The Last 14 Days
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February 10, 2016
16:06 EDTVNDAVanda sees FY16 net product sales $143M-$153M
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16:05 EDTVNDAVanda reports Q4 non-GAAP EPS (23c), consensus (26c)
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February 2, 2016
07:15 EDTVNDACanaccord to hold a conference
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