Ulcerative Colitis

• FDA approval · 2020-12-11
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab filed by Janssen Biotech, Inc. The action updates the product's labeling.

• FDA approval · 2020-12-01
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., reflecting an approval of changes to its label…

• FDA approval · 2020-10-29
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PENTASA (mesalamine) from Takeda Pharmaceuticals America, Inc., representing an FDA-approved…

• FDA approval · 2020-10-07
  FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dipentum (olsalazine sodium) from Viatris Specialty LLC.

• FDA approval · 2020-10-01
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for PENTASA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc., resulting in changes to …

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• FDA approval · 2020-10-01
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., resulting in updated labeling…

• FDA approval · 2020-10-01
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for mesalamine submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2020-08-14
  FDA Approved: MESALAMINE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s original ANDA for mesalamine, a generic version of the anti-inflammatory drug used to treat ulcerati…

• FDA approval · 2020-07-15
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for budesonide submitted by Padagis US LLC. The approval updates the labeling for budesonide under t…

• FDA approval · 2020-07-06
  FDA Approved: HULIO — Original Application (Biocon Biologics Inc)

  FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…

• FDA approval · 2020-06-26
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., indicating an approved change…

• FDA approval · 2020-05-29
  FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Mesalamine from Actavis Pharma, Inc. under ANDA203817, indicating an update for the generic prod…

• FDA approval · 2020-05-19
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Mesalamine from Zydus Lifesciences Limited.

• FDA approval · 2020-04-07
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)

  FDA approved a supplemental application for Mercaptopurine (Purixan) submitted by Nova Laboratories, Ltd.

• FDA approval · 2020-03-31
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Entyvio (vedolizumab) submitted by Takeda Pharmaceuticals America, resulting in updated appr…

• FDA approval · 2020-03-19
  FDA Approved: MESALAMINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original generic application for mesalamine.

• FDA approval · 2020-02-12
  FDA Approved: MESALAMINE — Original Application (Northstar Rx LLC.)

  FDA approved an original application for mesalamine (generic) submitted by Northstar Rx LLC.

• FDA approval · 2019-12-12
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) from Pfizer Laboratories Div Pfizer Inc, indicating an update to the pr…

• FDA approval · 2019-12-06
  FDA Approved: AVSOLA — Original Application (Amgen, Inc)

  FDA approved AVSOLA (infliximab-axxq) from Amgen as a biosimilar to infliximab, for the same indications as the reference product.

• FDA approval · 2019-11-20
  FDA Approved: MESALAMINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for MESALAMINE by Mylan Pharmaceuticals Inc. for a generic mesalamine product. The listing identifies …

• FDA approval · 2019-11-15
  FDA Approved: PREDNISONE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approves ANI Pharmaceuticals' original (generic) application for prednisone, enabling a generic prednisone product to be marketed.

• FDA approval · 2019-10-29
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide by Rite Aid Corporation, expanding or modifying the approval of this generic product.

• FDA approval · 2019-09-24
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc. The approval updates the drug's label…

• FDA approval · 2019-08-30
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, marking an approved modif…

• FDA approval · 2019-07-25
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA entry describing a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc.