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CDER New Molecular Entity (NME) Drug and New Biologic Approvals for Calendar Year 2008 Updated through December 31, 2008 NME New Drug Application (NDA) Approvals: Application Type
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Company

BAYER / GE / WYETH / EISAI / CEPHALON / GENZYME / AMGEN / /

IndustryTerm

TREATMENT OF REDUCING THE SIGNS AND SYMPTOMS / TREATMENT OF THE SIGNS AND SYMPTOMS / TREATMENT OF PROSTATE CANCER / TREATMENT OF HIV / TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA / TREATMENT OF MAJOR DEPRESSIVE DISORDER / /

MedicalCondition

PAIN / WITH EPILEPSY / CANCER / WITH CHRONIC LYMPHOCYTIC LEUKEMIA / FOR CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES / IDIOPATHIC (IMMUNE) THROMBOCYTOPENIC PURPURA / HUNTINGTON'S DISEASE / OF A DISEASE / OF MAJOR DEPRESSIVE DISORDER / OF OVERACTIVE BLADDER / METASTATIC PHEOCHROMOCYTOMAS / /

Organization

World Health Organization / /

Product

INTELENCE / TREANDA / ARCALYST / PRISTIQ / EOVIST INJECTION / VIMPAT TABLETS / /

PublishedMedium

PUBLIC LAW / /

Technology

MAGNETIC RESONANCE IMAGING / MRI / /

SocialTag