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calendar

28,990 catalysts · 9,430 approval · 5,000 device 510k · 4,728 grant · 2,701 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,430
  • device 510k5,000
  • grant4,728
  • 8k filing2,701
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings323
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 25, 2018

    22
    ›Jun 27, 2018approval2961d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d 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, 2018approval2960d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d 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, 2018approval2960d agoTRIACIN-C (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: ANIMA. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d agoFLOWTUSS (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d 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, 2018approval2960d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

    Sponsor: GENUS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 29, 2018approval2959d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Jun 29, 2018approval2959d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗

    Week of Jul 2, 2018

    6
    ›Jul 2, 2018approval2956d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jul 2, 2018approval

    Week of Jul 9, 2018

    4
    ›Jul 10, 2018approval2948d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Jul 11, 2018approval

    Week of Jul 16, 2018

    6
    ›Jul 16, 2018approval2942d 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, 2018approval

    Week of Jul 23, 2018

    12
    ›Jul 23, 2018approval2935d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →elagolix sodium →fda approvals ↗
    ›Jul 23, 2018approval
    ← prev
    page 7 of 580
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    2956d ago
    OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jul 2, 2018approval2956d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jul 3, 2018approval2955d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Jul 5, 2018approval2953d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →GLYCOPYRROLATE →fda approvals ↗
    ›Jul 6, 2018approval2952d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

    Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    2947d ago
    DALFAMPRIDINE — FDA approvaldalfampridine ER

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

    full page →dalfampridine ER →fda approvals ↗
    ›Jul 12, 2018approval2946d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Jul 13, 2018approval2945d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    2941d ago
    IMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Jul 19, 2018approval2939d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jul 20, 2018approval2938d agoGEMCITABINE HYDROCHLORIDE — FDA approvalGEMCITABINE HYDROCHLORIDE

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

    full page →GEMCITABINE HYDROCHLORIDE →fda approvals ↗
    ›Jul 20, 2018approval2938d agoSUMATRIPTAN AND NAPROXEN SODIUM (NAPROXEN SODIUM) — FDA approvalBayer HealthCare Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jul 20, 2018approval2938d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

    full page →alirocumab →fda approvals ↗
    2935d ago
    LAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jul 23, 2018approval2935d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jul 23, 2018approval2935d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jul 23, 2018approval2935d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jul 24, 2018approval2934d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →MEDROL →fda approvals ↗
    ›Jul 24, 2018approval2934d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
    ›Jul 24, 2018approval2934d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

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

    full page →methylprednisolone sodium succinate →fda approvals ↗
    ›Jul 25, 2018approval2933d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jul 26, 2018approval2932d agoGADAVIST (GADOBUTROL) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jul 26, 2018approval2932d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jul 27, 2018approval2931d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    $AMRX18.85+2.89%
    $AMRX18.85+2.89%
    $ANIP80.06+1.03%
    $TRAW
    $JNJ254.41-0.76%
    $LLY1121.36-2.39%
    $BMY65.47+0.24%
    $PFE25.03+0.08%
    $ABBV245.10-2.33%
    $REGN759.24-0.44%
    $PFE25.03+0.08%
    $AMRX18.85+2.89%