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calendar

25,822 catalysts · 16,936 approval · 3,617 device 510k · 2,351 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,351
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Aug 28, 2017

16
›Aug 29, 2017approval3290d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

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

full page →TUZISTRA XR →fda approvals ↗
›Aug 29, 2017approval3290d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗
›Aug 29, 2017approval3290d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Aug 29, 2017approval3290d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗
›Aug 29, 2017approval3290d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Aug 30, 2017approval3289d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗
›Aug 31, 2017approval3288d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
›Aug 31, 2017approval3288d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
›Aug 31, 2017approval3288d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
›Aug 31, 2017approval3288d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
›Aug 31, 2017approval3288d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Sep 4, 2017

7
›Sep 5, 2017approval3283d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 5, 2017approval3283d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Sep 6, 2017approval3282d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Sep 6, 2017approval3282d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗
›Sep 7, 2017approval3281d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗
›Sep 7, 2017approval3281d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Sep 8, 2017approval3280d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Week of Sep 11, 2017

6
›Sep 11, 2017approval3277d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

full page →FENOFIBRATE →fda approvals ↗
›Sep 14, 2017approval3274d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Sep 14, 2017approval3274d agoDYNA-HEX 4 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗
›Sep 14, 2017approval3274d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Sep 15, 2017approval3273d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Sep 15, 2017approval3273d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Week of Sep 18, 2017

9
›Sep 18, 2017approval3270d agoBUPROPION HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 19, 2017approval3269d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 19, 2017approval3269d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 19, 2017approval3269d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Sep 20, 2017approval3268d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗
›Sep 22, 2017approval3266d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Sep 22, 2017approval3266d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Sep 22, 2017approval3266d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

full page →fda approvals ↗
›Sep 22, 2017approval3266d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →TRAVOPROST →fda approvals ↗

Week of Sep 25, 2017

9
›Sep 25, 2017approval3263d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Sep 25, 2017approval3263d agoNEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗
›Sep 28, 2017approval3260d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

full page →Toujeo LA →fda approvals ↗
›Sep 28, 2017approval3260d agoDOXYCYCLINE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗
›Sep 29, 2017approval3259d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Sep 29, 2017approval3259d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗
›Sep 29, 2017approval3259d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

full page →insulin human →fda approvals ↗
›Sep 29, 2017approval3259d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗
›Sep 29, 2017approval3259d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Week of Oct 2, 2017

3
›Oct 5, 2017approval3253d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Oct 5, 2017approval3253d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Oct 5, 2017approval3253d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
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$TRAW
$ABBV255.48-1.03%
$NVS153.81-0.54%
$INDV34.87-1.22%
$INDV34.87-1.22%
$AMGN432.42-1.05%
$BMY66.58-0.55%
$NVS153.81-0.54%
$REGN794.19-1.67%
$BMY66.58-0.55%
$NVS153.81-0.54%
$AMPH22.01+0.59%
$MNKD3.9500-2.71%
$ABBV255.48-1.03%
$ABBV255.48-1.03%