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calendar

29,467 catalysts · 9,978 approval · 5,000 device 510k · 4,728 grant · 2,630 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,978
  • device 510k5,000
  • grant4,728
  • 8k filing2,630
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings317
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 27, 2017

    11
    ›Mar 27, 2017approval3417d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 27, 2017approval3417d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 27, 2017approval3417d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: AUROBINDO PHARMA. Form: SOLUTION. Route: ORAL

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 28, 2017approval3416d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →dupilumab →fda approvals ↗
    ›Mar 29, 2017approval3415d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 29, 2017approval3415d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 30, 2017approval3414d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Mar 30, 2017approval3414d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›Mar 31, 2017approval3413d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

    Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 31, 2017approval3413d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 31, 2017approval3413d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗

    Week of Apr 3, 2017

    8
    ›Apr 5, 2017approval3408d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

    Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Apr 5, 2017approval

    Week of Apr 10, 2017

    7
    ›Apr 11, 2017approval3402d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

    full page →fda approvals ↗
    ›Apr 11, 2017approval

    Week of Apr 17, 2017

    11
    ›Apr 17, 2017approval3396d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

    Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →atezolizumab →fda approvals ↗
    ›Apr 18, 2017approval

    Week of Apr 24, 2017

    13
    ›Apr 24, 2017approval3389d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Apr 24, 2017approval
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    page 3 of 590
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    3408d ago
    TROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

    Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Apr 5, 2017approval3408d agoISOVUE-250 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 5, 2017approval3408d agoISOVUE-370 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 5, 2017approval3408d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Apr 6, 2017approval3407d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

    Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Apr 6, 2017approval3407d agoIOPIDINE (APRACLONIDINE HYDROCHLORIDE) — FDA approvalHARROW, INC.

    Sponsor: HARROW EYE. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Apr 7, 2017approval3406d agoBUDESONIDE — FDA approvalbudesonide DR

    Sponsor: RISING. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

    full page →budesonide DR →fda approvals ↗
    3402d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 12, 2017approval3401d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

    Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 13, 2017approval3400d agoPIROXICAM — FDA approvalNostrum Pharmaceuticals LLC

    Sponsor: UNICHEM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Apr 13, 2017approval3400d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 13, 2017approval3400d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 13, 2017approval3400d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    3395d ago
    LAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 18, 2017approval3395d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 18, 2017approval3395d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Apr 18, 2017approval3395d agoLEFLUNOMIDE — FDA approvalLEFLUNOMIDE

    Sponsor: HERITAGE. Form: TABLET. Route: ORAL

    full page →LEFLUNOMIDE →fda approvals ↗
    ›Apr 19, 2017approval3394d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

    full page →fda approvals ↗
    ›Apr 20, 2017approval3393d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Apr 20, 2017approval3393d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Apr 20, 2017approval3393d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: PROTEGA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 21, 2017approval3392d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Apr 21, 2017approval3392d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →infliximab biosimilar →fda approvals ↗
    3389d ago
    RIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

    full page →RIFADIN →fda approvals ↗
    ›Apr 24, 2017approval3389d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →RIFATER →fda approvals ↗
    ›Apr 24, 2017approval3389d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

    full page →RIFADIN →fda approvals ↗
    ›Apr 24, 2017approval3389d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →alirocumab →fda approvals ↗
    ›Apr 24, 2017approval3389d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Apr 25, 2017approval3388d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Apr 25, 2017approval3388d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Saxenda →fda approvals ↗
    ›Apr 26, 2017approval3387d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 26, 2017approval3387d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 26, 2017approval3387d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3387d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 26, 2017approval3387d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    $NVS153.49-1.70%
    $SUPN44.63-2.15%
    $REGN763.54+0.12%
    $SUPN44.63-2.15%
    $AMRX18.32-0.97%
    $IGC0.2670+0.41%
    $HROW38.49-0.71%
    $ABBV246.00-1.97%
    $IGC0.2670+0.41%
    $HROW38.49-0.71%
    $REGN763.54+0.12%
    $BMY64.73-0.89%
    $NVO46.65-0.92%