Juvenile Idiopathic Arthritis

• FDA approval · 2019-07-23
  FDA Approved: HADLIMA — Original Application (Organon LLC)

  FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for a generic ibuprofen product. The approval confirms the ge…

• FDA approval · 2019-03-21
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) submitted by E.R. Squibb & Sons, L.L.C., indicating a labeling change and/or…

• FDA approval · 2018-10-30
  FDA Approved: ADALIMUMAB — Original Application (Sandoz Inc)

  FDA approved the original application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc. The approval covers the same indication…

• FDA approval · 2018-10-16
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

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• FDA approval · 2018-10-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation. The approval updates the labeling as descr…

• FDA approval · 2018-05-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The approval pertains to the supplement to…

• FDA approval · 2018-05-11
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The action updates the drug's labeling…

• FDA approval · 2018-04-30
  FDA Approved: CELECOXIB — Original Application (Micro Labs Limited)

  FDA approved the original generic application for celecoxib from Micro Labs Limited, providing a generic celecoxib option aligned with the r…

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2018-01-23
  FDA Approved: CELECOXIB — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' generic celecoxib as an Original Application (ANDA210071), enabling market entry for this COX-2 in…

• FDA approval · 2017-12-21
  FDA Approved: DOLEX FLEX — Original Application (Pharmadel LLC)

  FDA approved DOLEX FLEX (ibuprofen) through Pharmadel LLC's original ANDA.

• FDA approval · 2017-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) filed by Pfizer Laboratories Div Pfizer Inc, enabling the extended-rele…

• FDA approval · 2017-08-22
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC., expanding the product through a supple…

• FDA approval · 2017-06-30
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) submitted by E.R. Squibb & Sons, L.L.C. This action updates the product labe…

• FDA approval · 2017-03-10
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen by Zameer Pharmaceuticals LLC.

• FDA approval · 2017-03-07
  FDA Approved: METHOTREXATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for METHOTREXATE SODIUM from Fresenius Kabi USA, LLC.

• FDA approval · 2017-01-11
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  The FDA approved a supplemental application for OTREXUP (methotrexate) filed by Antares Pharma, Inc. This update expands the regulatory auth…

• FDA approval · 2016-09-16
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for celecoxib (generic) under ANDA204197.

• FDA approval · 2016-09-14
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for CELECOXIB from Aurobindo Pharma Limited (ANDA206827). This notice confirms the supplemental appr…

• FDA approval · 2016-09-01
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  The FDA approved a supplemental application for ZYBIC (meloxicam) filed by Redmont Pharmaceuticals, LLC.

• FDA approval · 2016-08-15
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM from Zydus Pharmaceuticals USA Inc., granting approval to market generic meloxicam in …

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Tolmetin sodium submitted by Atland Pharmaceuticals, LLC under ANDA073393.

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for tolmetin sodium submitted by Atland Pharmaceuticals, LLC.