Ankylosing Spondylitis

• FDA approval · 2019-10-26
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in an approved modification to the product’s lab…

• FDA approval · 2019-10-09
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Celecoxib submitted by Actavis Pharma, Inc.

• FDA approval · 2019-10-08
  FDA Approved: OLUMIANT — Supplemental Application (Eli Lilly and Company)

  FDA approves Eli Lilly's supplemental application for OLUMIANT (baricitinib). This action updates the labeling to reflect expanded indicatio…

• FDA approval · 2019-10-07
  FDA Approved: PIROXICAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for piroxicam by Micro Labs Limited, adding or updating a generic piroxicam 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…

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• FDA approval · 2019-08-07
  FDA Approved: CELECOXIB — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s original ANDA for celecoxib, establishing a generic version of the COX-2 inhibitor. The appro…

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for celecoxib from Apotex Corp., granting approval for a generic version of the product.

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for Celecoxib (generic Celecoxib), confirming the generic's approval. Celec…

• 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 · 2019-06-13
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

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

• FDA approval · 2019-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Harris Teeter)

  FDA approved Harris Teeter's diclofenac sodium as a generic under an original ANDA.

• FDA approval · 2018-11-29
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., confirming regulatory clearance for an updated product-rel…

• 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.

• 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 · 2018-07-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer's supplemental application to add ALEVE GELCAPS (naproxen sodium) as an additional formulation of naproxen products.

• 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 · 2018-03-20
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Cimzia (certolizumab pegol) filed by UCB, Inc.

• 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 · 2018-02-09
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc.

• 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 · 2017-08-22
  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 · 2017-06-22
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi (golimumab) submitted by Janssen Biotech, Inc.