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calendar

29,251 catalysts · 18,044 approval · 4,307 device 510k · 2,688 grant · 1,777 device recall · 1,480 device pma · 955 recall

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  • approval18,044
  • device 510k4,307
  • grant2,688
  • device recall1,777
  • device pma1,480
  • recall955
therapy area

no tagged catalysts yet

Week of Oct 18, 2021

9
›Oct 20, 2021approval1777d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 21, 2021approval1776d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗
›Oct 21, 2021approval1776d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗
›Oct 21, 2021approval1776d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗
›Oct 21, 2021approval1776d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗
›Oct 21, 2021approval1776d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗
›Oct 22, 2021approval1775d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Oct 22, 2021approval1775d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗
›Oct 22, 2021approval1775d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

Week of Oct 25, 2021

10
›Oct 25, 2021approval1772d agoHEPARIN SODIUM — FDA approvalPharmacia & Upjohn LLC

Sponsor: EMERGE BIOSCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 25, 2021approval1772d agoHEPARIN SODIUM — FDA approvalPharmacia & Upjohn LLC

Sponsor: EMERGE BIOSCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 25, 2021approval1772d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 25, 2021approval1772d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 26, 2021approval1771d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

full page →teprotumumab →fda approvals ↗
›Oct 27, 2021approval1770d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

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

full page →methylprednisolone sodium succinate →fda approvals ↗
›Oct 28, 2021approval1769d agoOXYCONTIN (OXYCODONE HYDROCHLORIDE) — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 28, 2021approval1769d agoALBUTEROL SULFATE — FDA approvalALBUTEROL SULFATE

Sponsor: CIPLA. Form: AEROSOL, METERED. Route: INHALATION

full page →ALBUTEROL SULFATE →fda approvals ↗
›Oct 29, 2021approval1768d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗
›Oct 29, 2021approval1768d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Week of Nov 1, 2021

10
›Nov 1, 2021approval1765d agoASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE) — FDA approvalWallace Pharmaceuticals Inc

Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Nov 2, 2021approval1764d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AMNEAL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
›Nov 2, 2021approval1764d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 2, 2021approval1764d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 3, 2021approval1763d agoDEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalBaxter Healthcare Corp

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

full page →fda approvals ↗
›Nov 3, 2021approval1763d agoRINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Nov 3, 2021approval1763d agoLACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalBaxter Healthcare Corp

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

full page →fda approvals ↗
›Nov 4, 2021approval1762d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

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

full page →fda approvals ↗
›Nov 4, 2021approval1762d agoDYANAVEL XR 20 (AMPHETAMINE) — FDA approvalDYANAVEL XR 20

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

full page →DYANAVEL XR 20 →fda approvals ↗
›Nov 5, 2021approval1761d agoEPRONTIA (TOPIRAMATE) — FDA approvaltopiramate ER

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →topiramate ER →fda approvals ↗

Week of Nov 8, 2021

13
›Nov 8, 2021approval1758d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 8, 2021approval1758d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 8, 2021approval1758d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

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

full page →fda approvals ↗
›Nov 8, 2021approval1758d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 8, 2021approval1758d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 9, 2021approval1757d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗
›Nov 9, 2021approval1757d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗
›Nov 10, 2021approval1756d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 10, 2021approval1756d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Nov 10, 2021approval1756d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Nov 12, 2021approval1754d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

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

full page →fda approvals ↗
›Nov 12, 2021approval1754d agoFULVESTRANT — FDA approvalFULVESTRANT

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

full page →FULVESTRANT →fda approvals ↗
›Nov 12, 2021approval1754d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Week of Nov 15, 2021

8
›Nov 16, 2021approval1750d agoPALIPERIDONE — FDA approvalEskayef Pharmaceuticals Ltd

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

full page →fda approvals ↗
›Nov 17, 2021approval1749d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗
›Nov 17, 2021approval1749d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗
›Nov 17, 2021approval1749d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗
›Nov 19, 2021approval1747d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 19, 2021approval1747d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
›Nov 19, 2021approval1747d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
›Nov 19, 2021approval1747d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗
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$ABBV256.42+0.37%
$TRAW
$AMRX17.47-0.40%
$RIGL45.69-1.69%
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$RDY12.13-0.41%
$NVS152.42-0.90%
$AMRX17.47-0.40%