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NMEs Approved by FDA’s CDER in Calendar Year 2011 Below is a list of the new molecular entities (NMEs) approved by the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) in c
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Company

Lennox / AMD / /

Event

Product Issues / /

IndustryTerm

magnetic resonance imaging / treatment of HIV / HIV therapy / treatment of Hodgkin lymphoma / /

MedicalCondition

suspected Parkinsonian syndromes / moderate-to-severe restless legs syndrome / systemic lupus erythematosus / major depressive disorder / hypertension / HIV / acute coronary syndromes / disease / castration-resistant prostate cancer / seizures / emphysema / lice infestation / chronic obstructive pulmonary disease / abnormal anaplastic lymphoma kinase / skin cancer / macular degeneration / bone marrow disease myelofibrosis / HAE / non-small cell lung cancers / chronic hepatitis C infection. rilpivirine / allergy / Hodgkin lymphoma / acute lymphoblastic leukemia / blood clots / melanoma / systemic anaplastic large cell lymphoma / hereditary angioedema / deep vein thrombosis / diabetes mellitus / heart attack / pulmonary embolism / hypersensitivity / epilepsy / diarrhea / infection / genetic blood disorder / thalassemia / high blood pressure / active / autoantibody-positive lupus / thyroid cancer / anemia / chronic hepatitis C. linagliptin / chronic bronchitis / blindness / severe chronic obstructive pulmonary disease / /

MedicalTreatment

chelation therapy / hip replacement surgery / kidney transplant / chemotherapy / knee surgery / surgery / blood transfusions / /

Organization

U.S. Food and Drug Administration / FDA / Center for Drug Evaluation and Research / /

Product

gabapentin / prednisone / response / /

Technology

magnetic resonance imaging / chemotherapy / MRI / /

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