Rheumatoid Arthritis

• 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 · 2019-11-14
  FDA Approved: CELECOXIB — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for a generic version of celecoxib (Celecoxib).

• 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 · 2019-10-22
  FDA Approved: MELOXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Meloxicam from Unichem Pharmaceuticals (USA), Inc. under ANDA 077927.

• FDA approval · 2019-10-17
  FDA Approved: PIROXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for PIROXICAM from Unichem Pharmaceuticals (USA), Inc. (a generic piroxicam product).

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• 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…

• FDA approval · 2019-09-11
  FDA Approved: OXAPROZIN — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Oxaprozin from Dr. Reddy's Laboratories Limited, updating the existing approval for this generic…

• 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 · 2019-08-30
  FDA Approved: RELAFEN DS — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approval of RELAFEN DS (nabumetone) through an original generic application by Carwin Pharmaceutical Associates, expanding access to thi…

• FDA approval · 2019-08-16
  FDA Approved: RINVOQ — Original Application (AbbVie Inc.)

  This FDA page documents the original FDA approval of Rinvoq (upadacitinib) from AbbVie under NDA211675, marking the first approval of this J…

• 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: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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

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

  FDA approved a supplemental application for XELJANZ XR (tofacitinib extended-release), expanding its formulation under Pfizer's submission.

• FDA approval · 2019-07-23
  FDA Approved: RUXIENCE — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Ruxience (rituximab-pvvr) from Pfizer as a biosimilar to rituximab, under an original application; the approval covers multiple…

• 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 · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ibuprofen from Chartwell RX, LLC under ANDA 202413, authorizing the specified changes to thi…

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

  FDA approved a supplemental application for ibuprofen by Amneal Pharmaceuticals of New York LLC.

• 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 · 2019-06-11
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) filed by Genentech, Inc., resulting in an approved update to the product's…