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calendar

29,284 catalysts · 18,062 approval · 4,312 device 510k · 2,691 grant · 1,782 device recall · 1,482 device pma · 955 recall

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  • approval18,062
  • device 510k4,312
  • grant2,691
  • device recall1,782
  • device pma1,482
  • recall955
therapy area

no tagged catalysts yet

Week of Jan 28, 2019

8
›Jan 29, 2019approval2772d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗
›Jan 31, 2019approval2770d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗
›Feb 1, 2019approval2769d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Feb 1, 2019approval2769d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Feb 1, 2019approval2769d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 1, 2019approval2769d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 2, 2019approval2768d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Feb 2, 2019approval2768d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Week of Feb 4, 2019

7
›Feb 4, 2019approval2766d agoLABETALOL HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Feb 4, 2019approval2766d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗
›Feb 4, 2019approval2766d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗
›Feb 5, 2019approval2765d agoDYANAVEL XR (AMPHETAMINE) — FDA approvalamfetamine ER

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

full page →amfetamine ER →fda approvals ↗
›Feb 6, 2019approval2764d agoCABLIVI (CAPLACIZUMAB-YHDP) — FDA approvalGenzyme Corp

Sponsor: ABLYNX NV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Feb 6, 2019approval2764d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 7, 2019approval2763d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Week of Feb 11, 2019

3
›Feb 11, 2019approval2759d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 14, 2019approval2756d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Feb 15, 2019approval2755d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Week of Feb 18, 2019

13
›Feb 20, 2019approval2750d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Feb 21, 2019approval2749d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 21, 2019approval2749d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 21, 2019approval2749d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 21, 2019approval2749d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗
›Feb 21, 2019approval2749d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

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

full page →fda approvals ↗
›Feb 21, 2019approval2749d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Feb 21, 2019approval2749d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 21, 2019approval2749d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Feb 22, 2019approval2748d agoMALARONE PEDIATRIC (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →atovaquone →fda approvals ↗
›Feb 22, 2019approval2748d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

full page →atovaquone →fda approvals ↗
›Feb 22, 2019approval2748d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 22, 2019approval2748d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Feb 25, 2019

9
›Feb 27, 2019approval2743d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Toujeo LA →fda approvals ↗
›Feb 27, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 27, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 27, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Feb 27, 2019approval2743d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗
›Feb 28, 2019approval2742d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗
›Feb 28, 2019approval2742d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗
›Feb 28, 2019approval2742d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

full page →RIFATER →fda approvals ↗
›Feb 28, 2019approval2742d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

Week of Mar 4, 2019

7
›Mar 5, 2019approval2737d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›Mar 6, 2019approval2736d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

full page →tedizolid phosphate →fda approvals ↗
›Mar 6, 2019approval2736d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗
›Mar 7, 2019approval2735d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Mar 8, 2019approval2734d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: WES PHARMA INC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 8, 2019approval2734d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Mar 8, 2019approval2734d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Week of Mar 11, 2019

3
›Mar 11, 2019approval2731d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗
›Mar 11, 2019approval2731d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Mar 11, 2019approval2731d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
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$REGN794.19-1.67%
$AMRX17.54-2.61%
$TRAW
$BMY66.58-0.55%
$AMRX17.54-2.61%
$AMGN432.42-1.05%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$SUPN43.73-1.04%
$BLNC
$BMY66.58-0.55%
$IGC0.2670+0.41%