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calendar

27,085 catalysts · 17,272 approval · 3,896 device 510k · 2,448 grant · 1,413 device recall · 1,196 device pma · 860 recall

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  • approval17,272
  • device 510k3,896
  • grant2,448
  • device recall1,413
  • device pma1,196
  • recall860
therapy area

no tagged catalysts yet

Week of Mar 4, 2013

8
›Mar 5, 2013approval4926d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Mar 6, 2013approval4925d agoTEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗
›Mar 6, 2013approval4925d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Mar 6, 2013approval4925d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Mar 7, 2013approval4924d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗
›Mar 8, 2013approval4923d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗
›Mar 8, 2013approval4923d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →BUTRANS →fda approvals ↗
›Mar 8, 2013approval4923d 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 Mar 11, 2013

7
›Mar 11, 2013approval4920d agoIRBESARTAN — FDA approvalIRBESARTAN

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

full page →IRBESARTAN →fda approvals ↗
›Mar 12, 2013approval4919d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 12, 2013approval4919d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 12, 2013approval4919d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 14, 2013approval4917d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Mar 14, 2013approval4917d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Mar 14, 2013approval4917d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Mar 18, 2013

7
›Mar 18, 2013approval4913d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗
›Mar 19, 2013approval4912d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
›Mar 19, 2013approval4912d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗
›Mar 19, 2013approval4912d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗
›Mar 19, 2013approval4912d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Mar 19, 2013approval4912d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Mar 22, 2013approval4909d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

full page →DIFLUPREDNATE →fda approvals ↗

Week of Mar 25, 2013

13
›Mar 25, 2013approval4906d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗
›Mar 25, 2013approval4906d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗
›Mar 25, 2013approval4906d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗
›Mar 26, 2013approval4905d agoMIFEPREX (MIFEPRISTONE) — FDA approvalCORCEPT THERAPEUTICS INC

Sponsor: DANCO LABS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 27, 2013approval4904d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

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

full page →fda approvals ↗
›Mar 27, 2013approval4904d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: TRIS PHARMA INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 27, 2013approval4904d agoVORICONAZOLE — FDA approvalMylan Pharmaceuticals Inc

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

full page →fda approvals ↗
›Mar 28, 2013approval4903d agoKARBINAL ER (CARBINOXAMINE MALEATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Mar 28, 2013approval4903d agoKETOROLAC TROMETHAMINE — FDA approvalKetorolac Tromethamine Apotex

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

full page →Ketorolac Tromethamine Apotex →fda approvals ↗
›Mar 28, 2013approval4903d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

full page →naltrexone ER →fda approvals ↗
›Mar 29, 2013approval4902d agoVENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Mar 29, 2013approval4902d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 29, 2013approval4902d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

full page →fda approvals ↗

Week of Apr 1, 2013

6
›Apr 1, 2013approval4899d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗
›Apr 1, 2013approval4899d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Apr 1, 2013approval4899d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

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

full page →fda approvals ↗
›Apr 2, 2013approval4898d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

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

full page →fda approvals ↗
›Apr 4, 2013approval4896d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

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

full page →fda approvals ↗
›Apr 5, 2013approval4895d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

full page →carbidopa →fda approvals ↗

Week of Apr 8, 2013

7
›Apr 9, 2013approval4891d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Apr 10, 2013approval4890d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Apr 10, 2013approval4890d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
›Apr 11, 2013approval4889d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

full page →fda approvals ↗
›Apr 11, 2013approval4889d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Apr 11, 2013approval4889d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Apr 12, 2013approval4888d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Week of Apr 15, 2013

2
›Apr 15, 2013approval4885d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Apr 15, 2013approval4885d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
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$RDY12.18+0.16%
$RDY12.18+0.16%
$KVUE19.17-0.16%
$RDY12.18+0.16%
$NVS153.81-0.54%
$TRAW
$CORT113.88-2.61%
$PFE27.96-0.21%
$NVS153.81-0.54%
$NVS153.81-0.54%
$AYTU2.2300-0.89%
$ALKS47.41-3.05%
$KVUE19.17-0.16%
$ORN12.42-2.13%