Rheumatoid Arthritis

• FDA approval · 2020-07-28
  FDA Approved: NAPROXEN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Naproxen from Glenmark Pharmaceuticals to update the labeling for the generic product under the …

• FDA approval · 2020-07-06
  FDA Approved: HULIO — Original Application (Biocon Biologics Inc)

  FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…

• FDA approval · 2020-06-01
  FDA Approved: MELOXICAM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' MELOXICAM as an original-application generic meloxicam; the drug is indicated for relief of pain and inf…

• FDA approval · 2020-05-08
  FDA Approved: IBUPROFEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's ibuprofen generic under Original Application (ANDA213794). The product is a generic version of ibupr…

• FDA approval · 2020-04-09
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

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

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• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2020-04-01
  FDA Approved: ARTHRITIS PAIN RELIEVER — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for Publix Super Markets Inc's arthritis pain reliever containing diclofenac sodium under an ANDA.

• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved Creekwood Pharmaceuticals LLC's supplemental application for hydroxychloroquine sulfate, authorizing the continued marketin…

• FDA approval · 2020-03-19
  FDA Approved: NAPROXEN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for naproxen (generic) under ANDA075390. This action constitutes a suppleme…

• FDA approval · 2020-03-06
  FDA Approved: CELECOXIB — Original Application (Chartwell RX, LLC)

  FDA approved the original generic application for celecoxib (Celecoxib) by Chartwell RX, LLC.

• FDA approval · 2020-02-25
  FDA Approved: CELECOXIB — Original Application (EPIC PHARMA, LLC)

  FDA approved the Original Application (ANDA) for a generic Celecoxib product from Epic Pharma, LLC, enabling its marketing as a COX-2 inhibi…

• FDA approval · 2020-02-19
  FDA Approved: DICLOFENAC SODIUM MISOPROSTOL — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original application for diclofenac sodium and misoprostol, a generic diclofenac/misoprostol combination product manufactur…

• FDA approval · 2020-02-18
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited for Naproxen and Esomeprazole Magnesium under an Original Application (ANDA) for a generic Nap…

• FDA approval · 2020-02-14
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) by Haleon US Holdings LLC to expand the labeling for…

• FDA approval · 2020-02-04
  FDA Approved: LEFLUNOMIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the original application for Leflunomide from Lupin Pharmaceuticals, establishing a generic version of the drug.

• FDA approval · 2020-01-30
  FDA Approved: METHOTREXATE — Original Application (Chartwell RX, LLC)

  FDA approvedChartwell RX, LLC's methotrexate product under an Original Application, making a new generic version of methotrexate available. …

• FDA approval · 2019-12-23
  FDA Approved: PIROXICAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Piroxicam (PIROXICAM). This is a supplemental approval affecting the PIROXICAM product.

• FDA approval · 2019-12-23
  FDA Approved: PENICILLAMINE — Original Application (Endo USA, Inc.)

  The FDA approved Endo USA, Inc.'s generic penicillamine. The generic is approved for the treatment of Wilson disease and rheumatoid arthriti…

• FDA approval · 2019-12-12
  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, indicating an update to the pr…

• FDA approval · 2019-12-06
  FDA Approved: AVSOLA — Original Application (Amgen, Inc)

  FDA approved AVSOLA (infliximab-axxq) from Amgen as a biosimilar to infliximab, for the same indications as the reference product.

• FDA approval · 2019-12-03
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Lifsa Drugs LLC)

  FDA approved the original application for diclofenac potassium as a generic NSAID for relief of pain and inflammation associated with variou…

• FDA approval · 2019-12-02
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for meloxicam by Aurobindo Pharma Limited. The approval covers changes approved under this supplemen…

• FDA approval · 2019-11-27
  FDA Approved: CELECOXIB — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved NIVAGEN Pharmaceuticals, Inc.'s original application for a generic celecoxib product.

• FDA approval · 2019-11-22
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  FDA approved a supplemental application for Naproxen Sodium from CVS under ANDA 091353, resulting in updated approval for the product.

• FDA approval · 2019-11-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic Naproxen product from Hikma Pharmaceuticals USA Inc. This action expands access to…