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calendar

29,794 catalysts · 18,165 approval · 4,368 device 510k · 2,977 grant · 1,806 device recall · 1,519 device pma · 959 recall

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  • approval18,165
  • device 510k4,368
  • grant2,977
  • device recall1,806
  • device pma1,519
  • recall959
therapy area

no tagged catalysts yet

Week of Aug 9, 2010

2
›Aug 12, 2010approval5862d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Aug 13, 2010approval5861d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Week of Aug 16, 2010

2
›Aug 18, 2010approval5856d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
›Aug 18, 2010approval5856d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

Week of Aug 23, 2010

1
›Aug 24, 2010approval5850d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Week of Aug 30, 2010

4
›Aug 30, 2010approval5844d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 30, 2010approval5844d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗
›Aug 31, 2010approval5843d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗
›Aug 31, 2010approval5843d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

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

full page →TRAVOPROST →fda approvals ↗

Week of Sep 6, 2010

2
›Sep 8, 2010approval5835d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Sep 8, 2010approval5835d agoLORAZEPAM — FDA approvallorazepam ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →lorazepam ER →fda approvals ↗

Week of Sep 13, 2010

3
›Sep 13, 2010approval5830d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

full page →fda approvals ↗
›Sep 13, 2010approval5830d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗
›Sep 17, 2010approval5826d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

Week of Sep 20, 2010

4
›Sep 22, 2010approval5821d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Sep 23, 2010approval5820d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →KESIMPTA →fda approvals ↗
›Sep 24, 2010approval5819d agoOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗
›Sep 24, 2010approval5819d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Week of Sep 27, 2010

6
›Sep 27, 2010approval5816d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
›Sep 29, 2010approval5814d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Sep 29, 2010approval5814d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗
›Sep 29, 2010approval5814d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Sep 30, 2010approval5813d agoARCALYST (RILONACEPT) — FDA approvalrilonacept

Sponsor: KINIKSA PHARMACEUTICALS (UK), LTD.. Form: VIAL. Route: SINGLE-USE

full page →rilonacept →fda approvals ↗
›Oct 1, 2010approval5812d agoDURAMORPH PF (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Kapanol →fda approvals ↗

Week of Oct 4, 2010

8
›Oct 4, 2010approval5809d agoPROSCAR (FINASTERIDE) — FDA approvalPROSCAR

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →PROSCAR →fda approvals ↗
›Oct 6, 2010approval5807d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗
›Oct 6, 2010approval5807d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Oct 6, 2010approval5807d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Oct 6, 2010approval5807d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Oct 6, 2010approval5807d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Oct 6, 2010approval5807d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗
›Oct 8, 2010approval5805d agoATELVIA (RISEDRONATE SODIUM) — FDA approvalAllergan Finance LLC

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

full page →fda approvals ↗

Week of Oct 11, 2010

5
›Oct 11, 2010approval5802d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORION PHARMA. Form: TABLET. Route: ORAL

full page →carbidopa →fda approvals ↗
›Oct 12, 2010approval5801d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗
›Oct 13, 2010approval5800d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Oct 15, 2010approval5798d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗
›Oct 15, 2010approval5798d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗

Week of Oct 18, 2010

13
›Oct 18, 2010approval5795d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗
›Oct 18, 2010approval5795d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

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

full page →METADATE CD →fda approvals ↗
›Oct 19, 2010approval5794d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 19, 2010approval5794d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 20, 2010approval5793d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 20, 2010approval5793d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 20, 2010approval5793d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 22, 2010approval5791d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 22, 2010approval5791d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 22, 2010approval5791d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 24, 2010approval5789d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 24, 2010approval5789d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 24, 2010approval5789d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
← prev
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$OGN13.760.00%
$INDV35.30-1.47%
$ORN12.42-2.13%
$AMGN432.42-1.05%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$AMRX17.54-2.61%
$NVS153.81-0.54%
$ALKS47.41-3.05%
$ABBV255.48-1.03%
$ALKS47.41-3.05%
$AMGN432.42-1.05%
$PFE27.96-0.21%
$PFE27.96-0.21%
$AYTU2.2300-0.89%
$JNJ268.04+0.85%