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calendar

25,798 catalysts · 16,936 approval · 3,617 device 510k · 2,327 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,327
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Jun 25, 2018

27
›Jun 26, 2018approval2989d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Jun 27, 2018approval2988d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗
›Jun 27, 2018approval2988d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jun 27, 2018approval2988d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Jun 27, 2018approval2988d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jun 27, 2018approval2988d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: COSETTE. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoTRIACIN-C (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: ANIMA. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Jun 28, 2018approval2987d agoFLOWTUSS (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

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

full page →TUZISTRA XR →fda approvals ↗
›Jun 28, 2018approval2987d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

Sponsor: SOVEREIGN PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Jun 28, 2018approval2987d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Jun 29, 2018approval2986d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗
›Jun 29, 2018approval2986d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Week of Jul 2, 2018

6
›Jul 2, 2018approval2983d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Jul 2, 2018approval2983d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›Jul 2, 2018approval2983d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Jul 3, 2018approval2982d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗
›Jul 5, 2018approval2980d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →GLYCOPYRROLATE →fda approvals ↗
›Jul 6, 2018approval2979d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Week of Jul 9, 2018

4
›Jul 10, 2018approval2975d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Jul 11, 2018approval2974d agoDALFAMPRIDINE — FDA approvaldalfampridine ER

Sponsor: ACCORD HLTHCARE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →dalfampridine ER →fda approvals ↗
›Jul 12, 2018approval2973d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗
›Jul 13, 2018approval2972d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Week of Jul 16, 2018

6
›Jul 16, 2018approval2969d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Jul 17, 2018approval2968d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
›Jul 19, 2018approval2966d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Jul 20, 2018approval2965d agoGEMCITABINE HYDROCHLORIDE — FDA approvalGEMCITABINE HYDROCHLORIDE

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →GEMCITABINE HYDROCHLORIDE →fda approvals ↗
›Jul 20, 2018approval2965d agoSUMATRIPTAN AND NAPROXEN SODIUM (NAPROXEN SODIUM) — FDA approvalBayer HealthCare Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jul 20, 2018approval2965d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

Week of Jul 23, 2018

7
›Jul 23, 2018approval2962d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗
›Jul 23, 2018approval2962d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jul 23, 2018approval2962d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Jul 23, 2018approval2962d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jul 23, 2018approval2962d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Jul 24, 2018approval2961d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗
›Jul 24, 2018approval2961d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
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$BMY66.58-0.55%
$ABBV255.48-1.03%
$TRAW
$AMRX17.54-2.61%
$ANIP72.83-0.93%
$AVBP30.17-2.68%
$LLY1157.39-1.47%
$AMRX17.54-2.61%
$REGN794.19-1.67%
$JNJ268.04+0.85%
$PFE27.96-0.21%
$PFE27.96-0.21%