Rheumatoid Arthritis

• FDA approval · 2021-12-14
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in updated …

• FDA approval · 2021-12-02
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) filed by Genentech, Inc., resulting in updated labeling for the product.

• FDA approval · 2021-12-02
  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. The approval authorizes the ex…

• FDA approval · 2021-11-01
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine EN-Tabs (sulfasalazine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc. (ANDA089342).

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• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.

• FDA approval · 2021-10-22
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) from Genentech, expanding its labeling and/or indications. The action conf…

• FDA approval · 2021-10-15
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approves a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC. The approval…

• FDA approval · 2021-09-14
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2021-08-23
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate from Ipca Laboratories Limited, approving changes to an already-a…

• FDA approval · 2021-08-23
  FDA Approved: PENICILLAMINE — Original Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's penicillamine under its original application (ANDA 215409), enabling a generic version of pen…

• FDA approval · 2021-08-02
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Diclofenac Sodium and Misoprostol from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-07-15
  FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Original Application (Micro Labs Limited)

  FDA approved the original application for a generic fixed-dose combination of diclofenac sodium and misoprostol from Micro Labs Limited.

• FDA approval · 2021-06-17
  FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for INFLECTRA (infliximab-dyyb) from Pfizer Laboratories Div Pfizer Inc, marking FDA action on a bio…

• FDA approval · 2021-06-14
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  The FDA approved a supplemental application for TREXALL (methotrexate) filed by Teva Women's Health, Inc.

• FDA approval · 2021-04-30
  FDA Approved: SULINDAC — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for sulindac from Sun Pharmaceutical Industries, Inc., authorizing changes to its labeling and/o…

• FDA approval · 2021-04-29
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Etodolac (Apotex Corp.), approving a generic version of etodolac under an ANDA.

• FDA approval · 2021-04-29
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  FDA approves a supplemental application for nabumetone submitted by Chartwell RX, LLC. Nabumetone is an NSAID used for pain relief in condit…

• FDA approval · 2021-04-28
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for tolmetin sodium submitted by Atland Pharmaceuticals, LLC, resulting in updated labeling for …

• FDA approval · 2021-04-28
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  The FDA has approved a supplemental application for INDOCIN (indomethacin) by Zyla Life Sciences US LLC.

• FDA approval · 2021-04-28
  FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.

• FDA approval · 2021-04-28
  FDA Approved: NABUMETONE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for Nabumetone from ScieGen Pharmaceuticals Inc, resulting in updated labeling and potential new ind…

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for Indomethacin, approving a generic Indomethacin product.

• FDA approval · 2021-04-28
  FDA Approved: NABUMETONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Nabumetone.

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…