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City Philadelphia / / Company Priority Review / / Country United States / / Event FDA Phase / / IndustryTerm prevention of respiratory distress syndrome / pharmaceutical industry / web page spotlight / notable new products / imaging / biotechnology industry / important applications / regulatory tools / / MedicalCondition inhalational anthrax / positive acute lymphoblastic leukemia / recurrent prostate cancer / overactive bladder / rare diseases / basal cell carcinoma / multiple myeloma / colorectal cancer / castration-resistant prostate cancer / To treat Cushing’s disease / late-stage breast cancer / respiratory distress syndrome / skin cancer / multi-drug resistant pulmonary tuberculosis / advanced kidney cancer / multi-drug-resistant pulmonary tuberculosis / severely active rheumatoid arthritis / chronic kidney disease / embolism / multiple sclerosis / bone marrow disease / disorder / diarrhea / HIVassociated diarrhea / renal cell carcinoma / familial hypercholesterolemia / cystic fibrosis / illness / constipation / breast cancer / chronic bronchitis / bone marrow diseases / partial onset seizures / HIV infection / cancers / actinic keratosis / Alzheimer’s disease / bronchospasm / cancer / disease / chronic weight management / emphysema / chronic obstructive pulmonary disease / erectile dysfunction / rare disease / neutropenia / stroke / cognitive impairment / chronic idiopathic constipation / Gaucher disease / kidney failure / medullary thyroid cancer / Omontys peginesatide To treat anemia / diseases / late-stage prostate cancer / short bowel syndrome / open-angle glaucoma / chronic myelogenous leukemia / blood clot / venous thromboembolism / HIV/AIDS / dangerous blood clots / epilepsy / atrial fibrillation / infection / ocular hypertension / chronic myeloid leukemia / late-stage basal cell cancer / irritable bowel syndrome / certain patients receiving cancer / infectious disease / hypercholesterolemia / / MedicalTreatment parenteral nutrition / chemotherapy / intravenous feeding / surgery / enzyme replacement therapy / dialysis / / Organization Congress / FDA / FDA’s Center for Drug Evaluation and Research / / Product Velcade / tenofovir disoproxil fumarate / Stribild / testosterone / fluorouracil / F 18 / Prescription Drug / CY / Dates Met Under / Erivedge / / Technology Tomography / biotechnology / chemotherapy / drug development / dialysis / / URL http / SocialTag 
Ten Year Historic Comparison Ten Year Historic Comparison CDER’S 2012 NMEs