24 marzo 2008

FDA - EMEA , Aprovaciones 2008 .

Marzo 2008 :
Wyeth - Pristiq has received FDA approval for the treatment of depression.
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Febrero 2008 :
Novartis - Eucreas has received EU approval for type II diabetes. It combines the DDP-IV inhibitor vildagliptin (Galvus) with metformin.
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Wyeth - Xyntha has received FDA approval for the treatment of hemophilia A. Xyntha (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free) is a recombinant factor VIII product.
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Enero 2008 :
Bayer Schering - Nexavar (sorafenib), approved by Japan's ministry of health, labour and welfare for advanced metastatic and non-operable renal cell carcinoma (RCC). Bayer Schering’s multi-kinase inhibitor becomes the first oral targeted therapy for this indication in Japan.
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Bayer Schering - Zevalin (ibritumomab tiuxetan) antibody radio-immunotherapy approved by Japan's ministry of health, labour and welfare for non-Hodgkin's lymphoma and mantle cell lymphoma.
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Pfizer - Champix (varenicline), approved by Japan's ministry of health, labour and welfare for smoking cessation.
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Pfizer - Revatio (sildenafil) PDE-5 inhibitor approved by Japan's ministry of health, labour and welfare for the orphan use of pulmonary arterial hypertension.
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Nycomed - Alvesco (ciclesonide), an inhaled corticosteroid for asthma has received FDA approval.