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calendar

26,917 catalysts · 17,218 approval · 3,845 device 510k · 2,445 grant · 1,382 device recall · 1,167 device pma · 860 recall

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  • approval17,218
  • device 510k3,845
  • grant2,445
  • device recall1,382
  • device pma1,167
  • recall860
therapy area

no tagged catalysts yet

Week of Jan 25, 2021

5
›Jan 26, 2021approval2044d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jan 27, 2021approval2043d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

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

full page →fda approvals ↗
›Jan 28, 2021approval2042d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Jan 28, 2021approval2042d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗
›Jan 29, 2021approval2041d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Feb 1, 2021

16
›Feb 1, 2021approval2038d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗
›Feb 1, 2021approval2038d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗
›Feb 1, 2021approval2038d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗
›Feb 1, 2021approval2038d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗
›Feb 1, 2021approval2038d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗
›Feb 2, 2021approval2037d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗
›Feb 2, 2021approval2037d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗
›Feb 2, 2021approval2037d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗
›Feb 2, 2021approval2037d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗
›Feb 4, 2021approval2035d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗
›Feb 4, 2021approval2035d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 4, 2021approval2035d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 4, 2021approval2035d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 4, 2021approval2035d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 5, 2021approval2034d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

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

full page →fda approvals ↗
›Feb 5, 2021approval2034d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

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

full page →fda approvals ↗

Week of Feb 8, 2021

18
›Feb 8, 2021approval2031d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗
›Feb 8, 2021approval2031d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 8, 2021approval2031d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 9, 2021approval2030d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

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

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
›Feb 9, 2021approval2030d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗
›Feb 9, 2021approval2030d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗
›Feb 10, 2021approval2029d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Feb 10, 2021approval2029d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 10, 2021approval2029d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 10, 2021approval2029d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Feb 10, 2021approval2029d agoIDARUBICIN HYDROCHLORIDE — FDA approvalIDARUBICIN HYDROCHLORIDE

Sponsor: PFIZER. Form: SOLUTION. Route: INTRAVENOUS

full page →IDARUBICIN HYDROCHLORIDE →fda approvals ↗
›Feb 11, 2021approval2028d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
›Feb 11, 2021approval2028d agoEVKEEZA (EVINACUMAB-DGNB) — FDA approvalevinacumab

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

full page →evinacumab →fda approvals ↗

Week of Feb 15, 2021

11
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 16, 2021approval2023d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Feb 16, 2021approval2023d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 17, 2021approval2022d agoHALOPERIDOL — FDA approvalHALOPERIDOL

Sponsor: AIPING PHARM INC. Form: TABLET. Route: ORAL

full page →HALOPERIDOL →fda approvals ↗
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$ABBV256.42+0.37%
$REGN799.08+0.62%
$ABBV256.42+0.37%
$ABBV256.42+0.37%
$IGC0.2670+0.41%
$REGN799.08+0.62%
$VTRS16.51+1.04%
$LLY1157.39-1.47%
$ABBV256.42+0.37%
$ABBV256.42+0.37%
$PFE28.46+1.79%
$ABBV256.42+0.37%
$IGC0.2670+0.41%
$REGN799.08+0.62%
$PFE28.46+1.79%