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New Drug Applications Archive - November 2005

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November 1, 2005

AstraZeneca Submits New Drug Application for Toprol-XL (metoprolol succinate)/Hydrochlorothiazide Combination Tablets for the Management of Hypertension

November 15, 2005

DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec
MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS

November 16, 2005

FDA Advisory Committee Recommends Additional Study Data to Support Approval of Certican in Heart Transplant Recipients

November 18, 2005

Eisai Resubmits NDA for the Anti-epilepsy Drug Rufinamide

November 23, 2005

FDA Issues Approvable Letter for Blood-Pool Contrast Agent Vasovist

November 24, 2005

Shire Files Elaprase (idursulfase) With the FDA for the Treatment of Hunter Syndrome

November 28, 2005

ALZA Corporation Resubmits U.S. New Drug Application for IONSYS (Fentanyl HCl Patient-Activated Transdermal System)

November 29, 2005

Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue

November 30, 2005

New Drug Application Submitted for Paliperidone - a Potential New Treatment for Schizophrenia

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