Rheumatoid Arthritis

• FDA approval · 2008-04-07
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Orencia (abatacept) submitted by E.R. Squibb & Sons, L.L.C., resulting in an update to its l…

• CLINICAL_TRIALS approval · 2008-04-01
  Clinical Trial Update: Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

  Abbott announced marketing approval for a human anti-TNF monoclonal antibody for active rheumatoid arthritis.

• CLINICAL_TRIALS approval · 2008-04-01
  Clinical Trial Update: Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

  Adalimumab has received marketing approval for rheumatoid arthritis following an open-label efficacy and safety assessment.

• FDA approval · 2008-03-07
  FDA Approved: NABUMETONE — Original Application (Exelan Pharmaceuticals Inc.)

  FDA approved Nabumetone as a generic product under an original ANDA submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2008-02-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Teva Pharmaceuticals USA, Inc. The action represents an …

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• FDA approval · 2008-02-05
  FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for sulindac from Actavis Pharma, Inc. This action updates the labeling for the drug under the appro…

• FDA approval · 2008-01-14
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Celebrex (celecoxib) submitted by Viatris Specialty LLC to update the product labeling under NDA…

• FDA approval · 2007-12-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for cyclosporine from Apotex Corp. This action approves additional labeling or supply under the supp…

• FDA approval · 2007-11-20
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Meloxicam filed by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2007-11-07
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…

• FDA approval · 2007-10-25
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved a supplemental application for MELOXICAM from AiPing Pharmaceutical, Inc., resulting in the availability of a generic meloxicam…

• FDA approval · 2007-10-16
  FDA Approved: MELOXICAM — Supplemental Application (Terrain Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for meloxicam from Terrain Pharmaceuticals, Inc., confirming continued approval for its approved…

• FDA approval · 2007-09-25
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…

• FDA approval · 2007-09-21
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original ANDA for hydroxychloroquine sulfate, a generic version manufactured by Zydus Lifesciences Limited.

• FDA approval · 2007-08-24
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the Diclofenac sodium and misoprostol combination product from Mylan Pharmaceuticals.

• FDA approval · 2007-08-01
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for NEORAL (cyclosporine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2007-07-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2007-07-26
  FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…

• FDA approval · 2007-07-15
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  The FDA approved Granules India Ltd's supplemental application for Naproxen (naproxen sodium). This action approves a generic naproxen sodiu…

• FDA approval · 2007-06-20
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approves a supplemental application for Plaquenil (hydroxychloroquine sulfate) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2007-06-14
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Ipca Laboratories Limited)

  FDA approved Ipca Laboratories Limited's original application for hydroxychloroquine sulfate as a generic product.

• FDA approval · 2007-06-12
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for infliximab (Remicade) submitted by Janssen Biotech, Inc. The approval updates the labeling to re…

• FDA approval · 2007-04-30
  FDA Approved: METHOTREXATE — Original Application (Accord Healthcare, Inc.)

  The FDA approved Accord Healthcare's original application for Methotrexate (generic).

• FDA approval · 2007-04-19
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab (Remicade) from Janssen Biotech, Inc., updating the product labeling per the supp…

• FDA approval · 2007-03-29
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for MELOXICAM from Lupin Pharmaceuticals, Inc., indicating regulatory clearance for an updated l…