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calendar

25,798 catalysts · 16,936 approval · 3,617 device 510k · 2,327 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,327
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Jul 29, 2013

11
›Jul 31, 2013approval4778d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jul 31, 2013approval4778d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jul 31, 2013approval4778d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Jul 31, 2013approval4778d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

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

full page →fda approvals ↗
›Jul 31, 2013approval4778d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗
›Jul 31, 2013approval4778d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalHikma Pharmaceuticals Plc

Sponsor: HIKMA PHARMS. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Jul 31, 2013approval4778d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Jul 31, 2013approval4778d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jul 31, 2013approval4778d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗
›Aug 2, 2013approval4776d agoBINOSTO (ALENDRONATE SODIUM) — FDA approvalOrganon & Co.

Sponsor: RADIUS. Form: TABLET, EFFERVESCENT. Route: ORAL

full page →fda approvals ↗
›Aug 2, 2013approval4776d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

full page →fda approvals ↗

Week of Aug 5, 2013

5
›Aug 5, 2013approval4773d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗
›Aug 8, 2013approval4770d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Aug 8, 2013approval4770d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗
›Aug 9, 2013approval4769d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗
›Aug 9, 2013approval4769d agoFLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

Sponsor: PADAGIS ISRAEL. Form: OIL. Route: TOPICAL

full page →fda approvals ↗

Week of Aug 12, 2013

12
›Aug 12, 2013approval4766d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗
›Aug 12, 2013approval4766d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Aug 13, 2013approval4765d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Aug 13, 2013approval4765d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

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

full page →fda approvals ↗
›Aug 13, 2013approval4765d agoBREVIBLOC (ESMOLOL HYDROCHLORIDE) — FDA approvalESMOLOL HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗
›Aug 14, 2013approval4764d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗
›Aug 14, 2013approval4764d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗
›Aug 16, 2013approval4762d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Aug 16, 2013approval4762d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Aug 16, 2013approval4762d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Aug 16, 2013approval4762d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Aug 16, 2013approval4762d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Week of Aug 19, 2013

3
›Aug 19, 2013approval4759d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE

full page →trastuzumab emtansine →fda approvals ↗
›Aug 22, 2013approval4756d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Aug 22, 2013approval4756d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Week of Aug 26, 2013

9
›Aug 26, 2013approval4752d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Aug 27, 2013approval4751d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Aug 28, 2013approval4750d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
›Aug 28, 2013approval4750d agoZIOPTAN (TAFLUPROST) — FDA approvaltafluprost

Sponsor: THEA PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →tafluprost →fda approvals ↗
›Aug 29, 2013approval4749d agoKADCYLA (ADO-TRASTUZUMAB EMTANSINE) — FDA approvaltrastuzumab emtansine

Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE

full page →trastuzumab emtansine →fda approvals ↗
›Aug 29, 2013approval4749d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Aug 30, 2013approval4748d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 30, 2013approval4748d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →Doxil →fda approvals ↗
›Aug 30, 2013approval4748d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →ropinirole hydrochloride ER →fda approvals ↗

Week of Sep 2, 2013

8
›Sep 4, 2013approval4743d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 4, 2013approval4743d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 4, 2013approval4743d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Sep 4, 2013approval4743d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Sep 4, 2013approval4743d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Sep 4, 2013approval4743d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Sep 5, 2013approval4742d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗
›Sep 6, 2013approval4741d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

full page →fda approvals ↗

Week of Sep 9, 2013

2
›Sep 10, 2013approval4737d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗
›Sep 13, 2013approval4734d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

full page →fda approvals ↗
← prev
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$PFE27.96-0.21%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$ABBV255.48-1.03%
$INDV34.87-1.22%
$COLL25.35-4.12%
$OGN13.760.00%
$SUPN43.73-1.04%
$ABBV255.48-1.03%
$RDY12.18+0.16%
$IGC0.2670+0.41%
$AMRX17.54-2.61%
$VTRS16.34-3.26%