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calendar

28,212 catalysts · 17,794 approval · 4,104 device 510k · 2,472 grant · 1,580 device recall · 1,358 device pma · 904 recall

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  • approval17,794
  • device 510k4,104
  • grant2,472
  • device recall1,580
  • device pma1,358
  • recall904
therapy area

no tagged catalysts yet

Week of May 5, 2014

5
›May 5, 2014approval4500d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

full page →PROPOFOL →fda approvals ↗
›May 7, 2014approval4498d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›May 8, 2014approval4497d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
›May 8, 2014approval4497d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
›May 9, 2014approval4496d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Week of May 12, 2014

12
›May 12, 2014approval4493d agoZIRGAN (GANCICLOVIR) — FDA approvalganciclovir

Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC

full page →ganciclovir →fda approvals ↗
›May 12, 2014approval4493d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

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

full page →fda approvals ↗
›May 12, 2014approval4493d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗
›May 13, 2014approval4492d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →ZOLEDRONIC ACID →fda approvals ↗
›May 14, 2014approval4491d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗
›May 14, 2014approval4491d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗
›May 14, 2014approval4491d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
›May 14, 2014approval4491d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›May 15, 2014approval4490d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›May 16, 2014approval4489d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

full page →estradiol ER →fda approvals ↗
›May 16, 2014approval4489d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›May 16, 2014approval4489d agoCHILDREN'S ZYRTEC HIVES (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗

Week of May 19, 2014

8
›May 20, 2014approval4485d agoTYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗
›May 20, 2014approval4485d agoENTYVIO (VEDOLIZUMAB) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›May 21, 2014approval4484d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›May 21, 2014approval4484d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗
›May 21, 2014approval4484d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗
›May 22, 2014approval4483d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗
›May 23, 2014approval4482d agoSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE) — FDA approvalRevalesio Corp

Sponsor: B BRAUN. Form: SOLUTION. Route: IRRIGATION

full page →fda approvals ↗
›May 23, 2014approval4482d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Week of May 26, 2014

3
›May 28, 2014approval4477d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗
›May 30, 2014approval4475d 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 ↗
›May 30, 2014approval4475d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

Week of Jun 2, 2014

10
›Jun 2, 2014approval4472d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: CONCENTRATE. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Jun 2, 2014approval4472d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jun 2, 2014approval4472d agoMS CONTIN (MORPHINE SULFATE) — FDA approvalKapanol

Sponsor: PURDUE PHARMA LP. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗
›Jun 2, 2014approval4472d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jun 5, 2014approval4469d agoFIORICET W/ CODEINE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Jun 5, 2014approval4469d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Jun 6, 2014approval4468d agoCEFEPIME AND DEXTROSE IN DUPLEX CONTAINER (CEFEPIME HYDROCHLORIDE) — FDA approvalSamson Medical Technologies LLC

Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Jun 6, 2014approval4468d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
›Jun 6, 2014approval4468d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗
›Jun 8, 2014approval4466d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

full page →PROPOFOL →fda approvals ↗

Week of Jun 9, 2014

12
›Jun 9, 2014approval4465d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

Sponsor: ALEMBIC. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →duloxetine hydrochloride DR →fda approvals ↗
›Jun 9, 2014approval4465d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗
›Jun 9, 2014approval4465d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jun 9, 2014approval4465d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jun 9, 2014approval4465d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Jun 9, 2014approval4465d agoPROSTIN VR PEDIATRIC (ALPROSTADIL) — FDA approvalalprostadil

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →alprostadil →fda approvals ↗
›Jun 9, 2014approval4465d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗
›Jun 9, 2014approval4465d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
›Jun 9, 2014approval4465d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

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

full page →methylprednisolone sodium succinate →fda approvals ↗
›Jun 10, 2014approval4464d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗
›Jun 10, 2014approval4464d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗
›Jun 10, 2014approval4464d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗
← prev
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$UTHR515.46-2.36%
$BLCO17.15+0.12%
$PFE27.96-0.21%
$NVS153.81-0.54%
$ABBV255.48-1.03%
$AMRX17.54-2.61%
$PFE27.96-0.21%
$NVS153.81-0.54%
$ABBV255.48-1.03%
$NVS153.81-0.54%
$KVUE19.17-0.16%
$IGC0.2670+0.41%
$INDV34.87-1.22%
$NVS153.81-0.54%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$NVS153.81-0.54%
$ABBV255.48-1.03%
$PFE27.96-0.21%
$PFE27.96-0.21%
$PFE27.96-0.21%
$PFE27.96-0.21%
$PFE27.96-0.21%
$PFE27.96-0.21%