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calendar

29,475 catalysts · 10,013 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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  • approval10,013
  • 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 Jan 30, 2017

    4
    ›Jan 30, 2017approval3472d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    ›Jan 31, 2017approval3471d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

    Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 31, 2017approval3471d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Feb 2, 2017approval3469d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗

    Week of Feb 6, 2017

    7
    ›Feb 8, 2017approval3463d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

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

    Week of Feb 13, 2017

    8
    ›Feb 13, 2017approval3458d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 13, 2017approval

    Week of Feb 20, 2017

    20
    ›Feb 21, 2017approval3450d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Feb 21, 2017approval

    Week of Feb 27, 2017

    3
    ›Feb 28, 2017approval3443d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

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

    Week of Mar 6, 2017

    8
    ›Mar 6, 2017approval3437d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 6, 2017approval
    ← prev
    page 2 of 590
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    3463d ago
    KALYDECO (IVACAFTOR) — FDA approvalivacaftor

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →ivacaftor →fda approvals ↗
    ›Feb 10, 2017approval3461d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Feb 10, 2017approval3461d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 10, 2017approval3461d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 10, 2017approval3461d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 10, 2017approval3461d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗
    3458d ago
    UNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 14, 2017approval3457d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ACTAVIS MID ATLANTIC. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Feb 15, 2017approval3456d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Feb 15, 2017approval3456d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    ›Feb 17, 2017approval3454d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

    Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 17, 2017approval3454d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

    Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →TUZISTRA XR →fda approvals ↗
    ›Feb 17, 2017approval3454d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

    Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    3450d ago
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMacleods Pharmaceuticals Ltd

    Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 21, 2017approval3450d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Feb 23, 2017approval3448d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

    Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Feb 23, 2017approval3448d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

    Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →aripiprazole LA →fda approvals ↗
    ›Feb 23, 2017approval3448d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 23, 2017approval3448d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 24, 2017approval3447d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Feb 24, 2017approval3447d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›Feb 24, 2017approval3447d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

    Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 24, 2017approval3447d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 24, 2017approval3447d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    3442d ago
    UNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

    Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Mar 3, 2017approval3440d agoTIZANIDINE HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

    Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    3437d ago
    DEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 6, 2017approval3437d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 7, 2017approval3436d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

    Sponsor: RISING. Form: SPRAY, METERED. Route: NASAL

    full page →BUTORPHANOL TARTRATE →fda approvals ↗
    ›Mar 8, 2017approval3435d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →linaclotide →fda approvals ↗
    ›Mar 10, 2017approval3433d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Mar 10, 2017approval3433d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Mar 10, 2017approval3433d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    $PFE25.01+0.40%
    $BMY65.31+0.69%
    $SNY43.08+0.44%
    $INDV40.10-2.17%
    $COLL35.39-1.64%
    $VERX12.91+2.46%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $VERX12.91+2.46%
    $IGC0.2670+0.41%
    $JNJ256.35+0.21%
    $ABBV250.94-2.51%
    $TRAW
    $RDY11.85+0.17%
    $PFE25.01+0.40%
    $RDY11.85+0.17%
    $TEVA35.01-1.13%
    $TEVA35.01-1.13%
    $TEVA35.01-1.13%
    $TEVA35.01-1.13%
    $ABBV250.94-2.51%
    $NVS156.15-1.45%
    $UTHR517.71-1.54%
    $ABBV250.94-2.51%
    $PFE25.01+0.40%
    $IGC0.2670+0.41%
    $ABBV250.94-2.51%
    $ABBV250.94-2.51%