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calendar

29,270 catalysts · 9,808 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,808
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • earnings311
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of May 22, 2017

    5
    ›May 26, 2017approval3356d agoNUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

    Sponsor: COLLEGIUM PHARM INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›May 26, 2017approval3356d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›May 26, 2017approval3356d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›May 26, 2017approval3356d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›May 26, 2017approval3356d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

    Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗

    Week of May 29, 2017

    4
    ›May 30, 2017approval3352d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

    Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 1, 2017approval

    Week of Jun 5, 2017

    2
    ›Jun 8, 2017approval3343d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

    Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 8, 2017approval

    Week of Jun 12, 2017

    16
    ›Jun 14, 2017approval3337d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 15, 2017approval

    Week of Jun 19, 2017

    11
    ›Jun 19, 2017approval3332d agoCOTEMPLA XR-ODT (METHYLPHENIDATE) — FDA approvalAYTU BIOPHARMA, INC

    Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 20, 2017approval

    Week of Jun 26, 2017

    12
    ›Jun 28, 2017approval3323d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval
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    page 3 of 586
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    3350d ago
    CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

    Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 1, 2017approval3350d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

    Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 1, 2017approval3350d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    3343d ago
    IRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    3336d ago
    VFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

    full page →fda approvals ↗
    ›Jun 15, 2017approval3336d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jun 15, 2017approval3336d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 16, 2017approval3335d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 16, 2017approval3335d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 16, 2017approval3335d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jun 16, 2017approval3335d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalGraviti Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 16, 2017approval3335d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Jun 16, 2017approval3335d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

    Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2017approval3334d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

    Sponsor: DR REDDYS LABS LTD. Form: CAPSULE. Route: ORAL

    full page →ISOTRETINOIN →fda approvals ↗
    3331d ago
    PAROXETINE MESYLATE — FDA approvalLegacy Pharma Solutions

    Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 20, 2017approval3331d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Jun 21, 2017approval3330d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jun 21, 2017approval3330d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jun 22, 2017approval3329d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jun 22, 2017approval3329d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Jun 22, 2017approval3329d agoPRIMAQUINE (PRIMAQUINE PHOSPHATE) — FDA approvalprimaquine phosphate

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

    full page →primaquine phosphate →fda approvals ↗
    ›Jun 22, 2017approval3329d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Jun 22, 2017approval3329d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 23, 2017approval3328d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    3322d ago
    TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval3322d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval3322d agoOTEZLA (APREMILAST) — FDA approvalapremilast

    Sponsor: AMGEN INC. Form: TABLET. Route: ORAL

    full page →apremilast →fda approvals ↗
    ›Jun 29, 2017approval3322d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

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

    full page →quetiapine fumarate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

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

    full page →quetiapine fumarate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

    Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

    Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    $COLL35.39-1.64%
    $GILD130.21-0.81%
    $NIU2.59000.00%
    $AYTU2.2300-0.89%
    $IGC0.2670+0.41%
    $NVS156.15-1.45%
    $NVS156.15-1.45%
    $RDY11.85+0.17%
    $NVS156.15-1.45%
    $AMGN385.16-0.64%