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calendar

26,823 catalysts · 17,207 approval · 3,831 device 510k · 2,445 grant · 1,345 device recall · 1,151 device pma · 844 recall

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  • approval17,207
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  • device recall1,345
  • device pma1,151
  • recall844
therapy area

no tagged catalysts yet

Week of Jan 9, 2017

4
›Jan 13, 2017approval3517d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jan 13, 2017approval3517d 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, 2017approval3517d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

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

full page →fda approvals ↗
›Jan 13, 2017approval3517d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Week of Jan 16, 2017

2
›Jan 18, 2017approval3512d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗
›Jan 19, 2017approval3511d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗

Week of Jan 23, 2017

16
›Jan 23, 2017approval3507d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Jan 24, 2017approval3506d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗
›Jan 24, 2017approval3506d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

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

full page →fda approvals ↗
›Jan 24, 2017approval3506d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: WATSON LABS TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 24, 2017approval3506d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: WATSON LABS TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jan 25, 2017approval3505d agoLANSOPRAZOLE — FDA approvallansoprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →lansoprazole DR →fda approvals ↗
›Jan 25, 2017approval3505d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗
›Jan 25, 2017approval3505d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗
›Jan 26, 2017approval3504d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Jan 27, 2017approval3503d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗
›Jan 27, 2017approval3503d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

full page →dulaglutide →fda approvals ↗
›Jan 27, 2017approval3503d 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 ↗
›Jan 27, 2017approval3503d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS

full page →Kapanol →fda approvals ↗
›Jan 27, 2017approval3503d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jan 28, 2017approval3502d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jan 28, 2017approval3502d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

Week of Jan 30, 2017

4
›Jan 30, 2017approval3500d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

full page →fda approvals ↗
›Jan 31, 2017approval3499d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Jan 31, 2017approval3499d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗
›Feb 2, 2017approval3497d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

Week of Feb 6, 2017

7
›Feb 8, 2017approval3491d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗
›Feb 8, 2017approval3491d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗
›Feb 10, 2017approval3489d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Feb 10, 2017approval3489d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 10, 2017approval3489d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 10, 2017approval3489d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 10, 2017approval3489d agoDILAUDID-HP (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗

Week of Feb 13, 2017

8
›Feb 13, 2017approval3486d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 13, 2017approval3486d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Feb 14, 2017approval3485d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ACTAVIS MID ATLANTIC. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Feb 15, 2017approval3484d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

full page →fda approvals ↗
›Feb 15, 2017approval3484d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Feb 17, 2017approval3482d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Feb 17, 2017approval3482d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

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

full page →TUZISTRA XR →fda approvals ↗
›Feb 17, 2017approval3482d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Feb 20, 2017

9
›Feb 21, 2017approval3478d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Feb 21, 2017approval3478d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMacleods Pharmaceuticals Ltd

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

full page →fda approvals ↗
›Feb 21, 2017approval3478d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Feb 23, 2017approval3476d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

full page →fda approvals ↗
›Feb 23, 2017approval3476d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗
›Feb 23, 2017approval3476d agoZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗
›Feb 23, 2017approval3476d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

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

full page →fda approvals ↗
›Feb 23, 2017approval3476d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

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

full page →fda approvals ↗
›Feb 23, 2017approval3476d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗
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