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calendar

29,536 catalysts · 10,026 approval · 5,000 device 510k · 4,728 grant · 2,651 8k filing · 2,000 device pma · 2,000 device recall

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  • approval10,026
  • device 510k5,000
  • grant4,728
  • 8k filing2,651
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings317
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 2, 2017

    21
    ›Jan 4, 2017approval3499d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

    Sponsor: AZURITY. Form: TABLET. Route: ORAL

    full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗
    ›Jan 4, 2017approval3499d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Jan 4, 2017approval3499d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

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

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

    Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Jan 4, 2017approval3499d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

    Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →METADATE CD →fda approvals ↗
    ›Jan 4, 2017approval3499d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

    Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →RITALIN LA →fda approvals ↗
    ›Jan 4, 2017approval3499d agoAPTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

    full page →fda approvals ↗
    ›Jan 4, 2017approval3499d agoDYANAVEL XR (AMPHETAMINE) — FDA approvalamfetamine ER

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

    full page →amfetamine ER →fda approvals ↗
    ›Jan 4, 2017approval3499d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

    Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2017approval3497d agoDESOXIMETASONE — FDA approvalSciegen Pharmaceuticals Inc

    Sponsor: SCIEGEN PHARMS. Form: CREAM. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 6, 2017approval3497d agoFLUOROURACIL — FDA approvalEfudex

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →Efudex →fda approvals ↗
    ›Jan 6, 2017approval3497d agoFLUOROURACIL — FDA approvalEfudex

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →Efudex →fda approvals ↗
    ›Jan 6, 2017approval3497d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 6, 2017approval3497d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →linaclotide →fda approvals ↗
    ›Jan 6, 2017approval3497d agoVISINE (NAPHAZOLINE HYDROCHLORIDE) — FDA approval

    Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Jan 6, 2017approval3497d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 6, 2017approval3497d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗

    Week of Jan 9, 2017

    24
    ›Jan 9, 2017approval3494d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

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

    full page →fda approvals ↗
    ›Jan 9, 2017approval

    Week of Jan 16, 2017

    2
    ›Jan 18, 2017approval3485d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 19, 2017approval

    Week of Jan 23, 2017

    3
    ›Jan 23, 2017approval3480d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 24, 2017approval
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    page 1 of 591
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    3494d ago
    MORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 10, 2017approval3493d agoABREVA (DOCOSANOL) — FDA approvalPL Developments Copiague LLC

    Sponsor: HALEON US HOLDINGS. Form: CREAM. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 11, 2017approval3492d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Jan 12, 2017approval3491d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 12, 2017approval3491d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Jan 13, 2017approval3490d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d 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 ↗
    ›Jan 13, 2017approval3490d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d 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 ↗
    ›Jan 13, 2017approval3490d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d 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 ↗
    ›Jan 13, 2017approval3490d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d 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 ↗
    ›Jan 13, 2017approval3490d agoPROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoTRIACIN-C (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: ANIMA. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d 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 ↗
    ›Jan 13, 2017approval3490d agoFLOWTUSS (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoPHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

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

    full page →TUZISTRA XR →fda approvals ↗
    ›Jan 13, 2017approval3490d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

    full page →fda approvals ↗
    ›Jan 13, 2017approval3490d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

    Sponsor: GENUS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    3484d ago
    PYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

    Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    3479d ago
    QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2017approval3479d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

    Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    $AYTU2.2300-0.89%
    $ABBV246.00-1.97%
    $TRAW
    $ABBV246.00-1.97%
    $COLL35.28-0.31%
    $TRAW
    $COLL35.28-0.31%
    $COLL35.28-0.31%
    $VERX13.35+3.37%
    $AMRX18.74+2.29%
    $TRAW
    $ANIP78.70-0.68%
    $INDV40.10-2.17%
    $COLL35.28-0.31%
    $AMRX18.74+2.29%