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calendar

29,251 catalysts · 18,044 approval · 4,307 device 510k · 2,688 grant · 1,777 device recall · 1,480 device pma · 955 recall

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  • approval18,044
  • device 510k4,307
  • grant2,688
  • device recall1,777
  • device pma1,480
  • recall955
therapy area

no tagged catalysts yet

Week of Aug 8, 2016

2
›Aug 9, 2016approval3674d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Aug 14, 2016approval3669d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Aug 15, 2016

6
›Aug 17, 2016approval3666d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Aug 17, 2016approval3666d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗
›Aug 18, 2016approval3665d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

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

full page →fda approvals ↗
›Aug 18, 2016approval3665d 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 ↗
›Aug 19, 2016approval3664d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Aug 19, 2016approval3664d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Week of Aug 22, 2016

8
›Aug 22, 2016approval3661d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗
›Aug 25, 2016approval3658d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Aug 25, 2016approval3658d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Aug 25, 2016approval3658d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗
›Aug 25, 2016approval3658d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗
›Aug 26, 2016approval3657d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Aug 26, 2016approval3657d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

full page →fda approvals ↗
›Aug 26, 2016approval3657d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Week of Aug 29, 2016

12
›Aug 30, 2016approval3653d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →KESIMPTA →fda approvals ↗
›Aug 30, 2016approval3653d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Aug 30, 2016approval3653d agoFORFIVO XL (BUPROPION HYDROCHLORIDE) — FDA approvalTWi Pharmaceuticals Inc

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

full page →fda approvals ↗
›Aug 30, 2016approval3653d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗
›Aug 30, 2016approval3653d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗
›Aug 30, 2016approval3653d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗
›Aug 31, 2016approval3652d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗
›Aug 31, 2016approval3652d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 2, 2016approval3650d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 2, 2016approval3650d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 2, 2016approval3650d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 2, 2016approval3650d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Sep 5, 2016

9
›Sep 6, 2016approval3646d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗
›Sep 7, 2016approval3645d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 8, 2016approval3644d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
›Sep 8, 2016approval3644d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗
›Sep 8, 2016approval3644d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗
›Sep 9, 2016approval3643d agoALLOPURINOL SODIUM — FDA approvalALLOPURINOL SODIUM

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →ALLOPURINOL SODIUM →fda approvals ↗
›Sep 9, 2016approval3643d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗
›Sep 9, 2016approval3643d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Sep 9, 2016approval3643d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Week of Sep 12, 2016

5
›Sep 13, 2016approval3639d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Sep 13, 2016approval3639d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Sep 15, 2016approval3637d agoDUOPA (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ABBVIE. Form: SUSPENSION. Route: ENTERAL

full page →carbidopa →fda approvals ↗
›Sep 16, 2016approval3636d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗
›Sep 16, 2016approval3636d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

Week of Sep 19, 2016

8
›Sep 19, 2016approval3633d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Sep 19, 2016approval3633d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Sep 19, 2016approval3633d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Sep 19, 2016approval3633d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 20, 2016approval3632d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 20, 2016approval3632d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

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

full page →Saxenda →fda approvals ↗
›Sep 22, 2016approval3630d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Sep 22, 2016approval3630d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

full page →fda approvals ↗
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$NVS153.81-0.54%
$PFE27.96-0.21%
$VERX14.22-0.52%
$BMY66.58-0.55%
$NVS153.81-0.54%
$SUPN43.73-1.04%
$AMRX17.54-2.61%
$AMGN432.42-1.05%
$PFE27.96-0.21%
$ABBV255.48-1.03%
$NVS153.81-0.54%
$AMGN432.42-1.05%
$BMY66.58-0.55%
$NVO45.61-1.41%
$GILD145.68-2.14%
$ABBV255.48-1.03%