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Food and Drug Administration / Piperazines / Eli Lilly and Company / New Drug Application / Pharmaceutical industry / Tapentadol / Levofloxacin / Ofloxacin / FDA Fast Track Development Program / Chemistry / Pharmacology / Organic chemistry


New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals As of December 31, 2012 Selection Criteria: User Response: Start Date: [removed]End Date: [removed]
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City

INTERFERON / /

Company

GILEAD SCIENCES INC / EMTRICITABINE/ TENOFOVIR DISOPROXIL FUMARATE BRACCO DIAGNOSTICS INC / EFFICACY PROPER NAME NATALIZUMAB APPLICANT BIOGEN IDEC INC. / RIVASTIGMINE NOVARTIS PHARMACEUTICALS CORP / MONTELUKAST SODIUM MERCK RESEARCH LABORATORIES DIV MERCK CO INC / TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC / SUPPL-24 PEDIATRIC IRON SUCROSE LUITPOLD PHARMACEUTICALS INC / NEW INDICATION NEW INDICATION CARBAMAZEPINE VALIDUS PHARMACEUTICALS INC / FOSAMPRENAVIR CALCIUM VIIV HEALTHCARE CO LEVOFLOXACIN JANSSEN PHARMACEUTICALS INC / S S BEVACIZUMAB GENENTECH INC. / FOXAMPRENAVIR CALCIUM VIIV HEALTHCARE CO WYETH PHARMACEUTICALS INC / GADOBENATE DIMEGLUMINE BRACCO DIAGNOSTICS INC / PEDIATRIC SAQUINAVIR MESYLATE HOFFMANN LA ROCHE INC / NEW INDICATION NEW INDICATION LIRAGLUTIDE NOVO NORDISK INC / SUPPL-1 NEW INDICATION TAPENTADOL JANSSEN PHARMACEUTICALS INC / CICLESONIDE FLUTICASONE PROPIONATE/ SALMETEROL NYCOMED GMBH / SUPPL-26 NEW PATIENT POPULATION ESZOPICLONE SUNOVION PHARMACEUTICALS INC / GLAXOSMITHKLINE / ETRAVIRINE JANSSEN RESEARCH AND DEVELOPMENT LLC / THALIDOMIDE CELGENE CORP / ORIG-2 EFFICACY PHENTERMINE HYDROCHLORIDE CITIUS PHARMACEUTICALS LLC / SUPPL-225 EFFICACY CETUXIMAB IMCLONE LLC / GENENTECH INC. / MEDIMMUNE LLC / SUPPL-1 NEW INDICATION ROTIGOTINE UCB INC / BORTEZOMIB MILLENNIUM PHARMACEUTICALS INC / GLAXO GROUP LTD / ABBOTT LABORATORIES / EZETIMIBE MSD INTERNATIONAL GMBH / S EVEROLIMUS/ SUNITINIB NOVARTIS PHARMACEUTICALS CORP / NILOTINIB GLAXOSMITHKLINE S NOVARTIS PHARMACEUTICALS CORP / 17BESTRADIOL BAYER HEALTHCARE PHARMACEUTICALS INC / HOFFMANN LA ROCHE INC / BRISTOL MYERS SQUIBB / LEVOFLOXACIN JANSSEN PHARMACEUTICALS INC / S ANAKINRA SWEDISH ORPHAN BIOVITRUM AB / ACCELERATED APPROVAL CONFIRMATORY STUDY IMATINIB MESYLATE NOVARTIS PHARMACEUTICALS CORP / ELI LILLY AND COMPANY / EFFICACY EFFICACY EFFICACY EFFICACY TOCILIZUMAB RITUXIMAB GENENTECH INC. / ALCON PHARMACEUTICALS LTD / S B BRAUN MEDICAL INC / NEW PATIENT POPULATION LISDEXAMFETAMINE DIMESYLATE SHIRE DEVELOPMENT INC / SUPPL-2 NEW INDICATION ROTIGOTINE UCB INC / PEDIATRIC NEW INDICATION PEDIATRIC LEVOFLOXACIN JANSSEN PHARMACEUTICALS INC / CARBAMAZEPINE VALIDUS PHARMACEUTICALS INC / S MONTELUKAST SODIUM MERCK AND CO INC / POPULATION NAB PACLITAXEL ENTECAVIR ABRAXIS BIOSCIENCE LLC / PAZOPANIB NEW DOSING REGIMEN SUNOVION LURASIDONE HYDROCHLORIDE PHARMACEUTICALS INC / OPENLABEL / ACETATE OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE JANSSEN BIOTECH INC / SUPPL-2 NEW INDICATION CALCIPOTRIEN STIEFEL LABORATORIES INC / SODIUM/ DEXTROSE APPLICANT PRIORITY REVIEW MERZ PHARMACEUTICALS LLC / INDICATION TAPENTADOL JANSSEN PHARMACEUTICALS INC / INDICATION CARBAMAZEPINE VALIDUS PHARMACEUTICALS INC / POPULATION ESZOPICLONE SUNOVION PHARMACEUTICALS INC / IRON SUCROSE LUITPOLD PHARMACEUTICALS INC / INC JANSSEN PHARMACEUTICALS INC / INDICATION EPINEPHRINE JHP PHARMACEUTICALS LLC / GROUP LTD ALCON PHARMACEUTICALS LTD / INDICATION CALCIPOTRIEN STIEFEL LABORATORIES INC / GLAXOSMITHKLINE S NOVARTIS PHARMACEUTICALS CORP / /

Event

FDA Phase / Product Issues / /

Facility

DUPLEX CONTAINER / /

IndustryTerm

TREATMENT OF HIV / TREATMENT OF 10.1 VASOMOTOR SYMPTOMS / /

MedicalCondition

MACULAR DEGENERATION / HIV RNA / DISORDER / SYSTEM INFLAMMATORY DISEASE / PROSTATE CANCER / TONIC-CLONIC SEIZURES / WITH ADVANCED SOFT TISSUE SARCOMA / LEGS SYNDROME / ADHD / CENTRAL RETINAL VEIN OCCLUSION / TUMORS / METASTATIC NONSMALL CELL LUNG CANCER / OF EXCERCISE-INDUCED BRONCHOCONSTRICTION / DIABETES / NEURALGIA / FOR PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY / PARKINSON’S DISEASE / INFECTION / OF DEEP VEIN THROMBOSIS / PULMONARY EMBOLISM / OF PULMONARY EMBOLISM / HYPERTENSION / KIDNEY DISEASE / DIFFUSE LARGE B-CELL LYMPHOMA / METASTATIC COLORECTAL CANCER / POSITIVE COLORECTAL CANCER / HYPERLIPIDEMIA / KIT (CD117) POSITIVE GASTROINTESTINAL STROMAL TUMORS / RLS / PAIN / FOR PREVIOUSLY UNTREATED FOLLICULAR NON-HODGKIN’S LYMPHOMA / /

MedicalTreatment

SURGERY / CONTRACEPTION / RADIATION THERAPY / LIVER TRANSPLANT / /

Organization

World Health Organization / FDA / CO INC / IN MEN / /

Position

PHYSICIAN / /

Product

CARBOPLATIN / CEFAZOLIN / GLEEVEC / RITUXAN / SIMVASTATIN / DEXTROSE / PHENTERMINE HYDROCHLORIDE / ESTRADIOL VALERATE / AVONEX / RIVASTIGMINE / CEFAZOLIN SODIUM / TENOFOVIR DISOPROXIL FUMARATE / NICOTINE POLACRILEX / PACLITAXEL / GABAPENTIN / FAMCICLOVIR / EPINEPHRINE / NEVIRAPINE / EXTENDED-RELEASE CAPSULES / CALCIPOTRIENE / PREDNISONE / AZATHIOPRINE / ERBITUX / METFORMIN HYDROCHLORIDE / PIOGLITAZONE / FLUTICASONE PROPIONATE / HUMIRA / CARBAMAZEPINE / PRAMIPEXOLE DIHYDROCHLORIDE / RISPERIDONE / MERCAPTOPURINE / LUCENTIS / LEXIVA / LEVOFLOXACIN / ESTRADIOL / EQUETRO / BETAMETHASONE DIPROPIONATE / FLUOROURACIL / SILDENAFIL CITRATE / SUPPL-16 / SUPPL-22 / SUPPL-34 / NV20911 / SUPPL-27 / SUPPL-26 / SUPPL-6 / SUPPL-53 / SUPPL-40 / OF / SUPPL-24 / SUPPL-38 / SUPPL-11 / TYPE / SUPPL-8 / Efficacy Supplement / SUPPL-39 / MG STRENGTH TABLET / SUPPL-19 / SUPPL-31 / SUPPL-23 / SUPPL-49 / SUPPL-13 / SUPPL-15 / PROVIDES / NDA / SUPPL-37 / SUPPL-10 / SUPPL-33 / SUPPL-3 / SUPPL-4 / SUPPL-2 / SUPPL-7 / SUPPL-1 / SUPPL-65 / ORIG-2 / Efficacy / SUPPL-9 / SUPPL-42 / RESPONSE / SUPPL-28 / SUPPL-59 / SUPPL-20 / SUPPL-123 / SUPPL-21 / SUPPL-5 / AI463085 / SUPPL-14 / SUPPL-41 / /

ProgrammingLanguage

L / ML / /

SportsEvent

NHL / /

Technology

RADIATION / CHEMOTHERAPY / /

SocialTag