Rheumatoid Arthritis

• FDA approval · 2022-09-28
  FDA Approved: ARTHRITIS PAIN RELIEVER — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for ARTHRITIS PAIN RELIEVER (diclofenac sodium) by Publix Super Markets Inc. This action approves ch…

• FDA approval · 2022-09-15
  FDA Approved: CELECOXIB — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for a generic celecoxib product from Westminster Pharmaceuticals, expanding access under ANDA210…

• FDA approval · 2022-09-06
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  The FDA approved a supplemental application for naproxen sodium sponsored by CVS.

• FDA approval · 2022-07-18
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz's supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ. The approval covers multiple inflammatory …

• FDA approval · 2022-07-18
  FDA Approved: FENOPRON TM — Original Application (Galt Pharmaceuticals, LLC)

  FDA approved Fenoprofen calcium as a generic tablet under an original ANDA submitted by Galt Pharmaceuticals, LLC.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2022-07-11
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2022-07-07
  FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for HYDROXYCHLOROQUINE from Chartwell RX, LLC under an ANDA, making a generic version available.

• FDA approval · 2022-06-17
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) from Immunex Corporation, resulting in labeling changes for the product.…

• FDA approval · 2022-06-07
  FDA Approved: NAPROXEN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber's naproxen generic original application for Naproxen. This generic NSAID is approved for relief of pain and inflammation…

• FDA approval · 2022-06-03
  FDA Approved: RIABNI — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for RIABNI (rituximab-arrx) from Amgen. The action updates RIABNI’s labeling to reflect its approved…

• FDA approval · 2022-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Apotex Corp.)

  FDA approved Apotex Corp's original application for diclofenac sodium tablets, a generic NSAID. This approval enables Apotex to market a gen…

• FDA approval · 2022-05-03
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) submitted by Advanz Pharma (US) Corp. This action constit…

• FDA approval · 2022-03-22
  FDA Approved: IBUPROFEN — Supplemental Application (Aurohealth LLC)

  The FDA approved a supplemental application for ibuprofen filed by Aurohealth LLC, authorizing the generic ibuprofen product.

• FDA approval · 2022-03-18
  FDA Approved: BROMFENAC — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for bromfenac from Aurobindo Pharma Limited, enabling a generic bromfenac product to enter the market.…

• FDA approval · 2022-03-11
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  FDA approved a supplemental application for naproxen sodium granules from Granules India Ltd, resulting in an approved supplemental request …

• FDA approval · 2022-03-09
  FDA Approved: CELECOXIB — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Celecoxib from Micro Labs Limited under an ANDA.

• FDA approval · 2022-02-08
  FDA Approved: PIROXICAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2022-02-02
  FDA Approved: CYCLOSPORINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for cyclosporine, a generic immunosuppressant product. This makes a generic cyc…

• FDA approval · 2022-01-14
  FDA Approved: SOVUNA — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved SOVUNA (hydroxychloroquine sulfate) under an original application by ANI Pharmaceuticals, Inc.

• FDA approval · 2022-01-11
  FDA Approved: CELECOXIB — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for Celecoxib submitted by NIVAGEN Pharmaceuticals, Inc., for a generic Celecoxib product.

• FDA approval · 2022-01-07
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for meloxicam, authorizing the generic NSAID product. This marks regulatory…

• FDA approval · 2022-01-07
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Aurobindo Pharma Limited.

• FDA approval · 2022-01-05
  FDA Approved: CELECOXIB — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic celecoxib product (Celecoxib) under ANDA 202240.

• FDA approval · 2021-12-17
  FDA Approved: YUSIMRY — Original Application (Coherus BioSciences Inc)

  FDA approved YUSIMRY (adalimumab-aqvh) from Coherus BioSciences in an original biologics license application, likely as a biosimilar to adal…

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

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc. The submission status …