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calendar

27,004 catalysts · 17,239 approval · 3,880 device 510k · 2,448 grant · 1,398 device recall · 1,179 device pma · 860 recall

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  • approval17,239
  • device 510k3,880
  • grant2,448
  • device recall1,398
  • device pma1,179
  • recall860
therapy area

no tagged catalysts yet

Week of Jul 6, 2015

1
›Jul 10, 2015approval4070d agoFOSAMAX PLUS D (ALENDRONATE SODIUM) — FDA approval(alendronate sodium + cholecalciferol)

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

full page →(alendronate sodium + cholecalciferol) →fda approvals ↗

Week of Jul 13, 2015

15
›Jul 13, 2015approval4067d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗
›Jul 14, 2015approval4066d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Jul 14, 2015approval4066d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗
›Jul 14, 2015approval4066d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
›Jul 15, 2015approval4065d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

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

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗
›Jul 15, 2015approval4065d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 15, 2015approval4065d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 15, 2015approval4065d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jul 15, 2015approval4065d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Jul 16, 2015approval4064d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Week of Jul 20, 2015

19
›Jul 20, 2015approval4060d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Jul 20, 2015approval4060d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jul 20, 2015approval4060d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jul 21, 2015approval4059d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗
›Jul 22, 2015approval4058d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

full page →ALENDRONATE SODIUM →fda approvals ↗
›Jul 22, 2015approval4058d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

full page →ALENDRONATE SODIUM →fda approvals ↗
›Jul 22, 2015approval4058d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

full page →ALENDRONATE SODIUM →fda approvals ↗
›Jul 22, 2015approval4058d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 22, 2015approval4058d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 22, 2015approval4058d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 23, 2015approval4057d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗
›Jul 23, 2015approval4057d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗
›Jul 23, 2015approval4057d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 23, 2015approval4057d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗
›Jul 24, 2015approval4056d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 24, 2015approval4056d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 24, 2015approval4056d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗
›Jul 24, 2015approval4056d agoALFENTA (ALFENTANIL HYDROCHLORIDE) — FDA approvalalfentanil hydrochloride

Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

full page →alfentanil hydrochloride →fda approvals ↗
›Jul 24, 2015approval4056d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

Week of Jul 27, 2015

8
›Jul 27, 2015approval4053d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗
›Jul 28, 2015approval4052d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Jul 28, 2015approval4052d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

full page →DIGOXIN →fda approvals ↗
›Jul 29, 2015approval4051d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗
›Jul 30, 2015approval4050d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 31, 2015approval4049d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗
›Jul 31, 2015approval4049d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: ACTAVIS LABS UT INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jul 31, 2015approval4049d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

Week of Aug 3, 2015

7
›Aug 3, 2015approval4046d agoPALIPERIDONE — FDA approvalEskayef Pharmaceuticals Ltd

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Aug 3, 2015approval4046d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 5, 2015approval4044d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗
›Aug 5, 2015approval4044d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 5, 2015approval4044d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Aug 6, 2015approval4043d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

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

full page →methylprednisolone sodium succinate →fda approvals ↗
›Aug 7, 2015approval4042d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
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$KVUE19.17-0.16%
$COLL25.35-4.12%
$OGN13.760.00%
$LLY1174.61-0.13%
$RDY12.18+0.16%
$RDY12.18+0.16%
$RDY12.18+0.16%
$TEVA36.44-3.14%
$RDY12.18+0.16%
$REGN794.19-1.67%
$RDY12.18+0.16%
$IGC0.2670+0.41%
$IGC0.2670+0.41%
$TEVA36.44-3.14%