Juvenile Idiopathic 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…

• 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 · 2007-11-20
  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…

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• 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 · 2007-07-30
  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 · 2007-06-12
  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 · 2007-04-19
  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…

• FDA approval · 2007-03-28
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted a supplemental approval for Meloxicam from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2007-03-13
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) from E.R. Squibb & Sons, L.L.C.

• FDA approval · 2006-12-20
  FDA Approved: MELOXICAM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original ANDA for Meloxicam, manufactured by Unichem Pharmaceuticals (USA), Inc., introducing a generic version of the NSAI…

• FDA approval · 2006-12-12
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) submitted by E.R. Squibb & Sons, L.L.C., indicating an approved update to th…

• FDA approval · 2006-12-08
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for infliximab submitted by Janssen Biotech, Inc.

• FDA approval · 2006-09-26
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., updating the drug's labeling.

• FDA approval · 2006-09-22
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for tolmetin sodium from Atland Pharmaceuticals, under ANDA074473. This action updates the regulator…

• FDA approval · 2006-07-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited, likely to authorize a new contract manufactur…

• FDA approval · 2006-07-19
  FDA Approved: MELOXICAM — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for MELOXICAM, a generic meloxicam product. This marks the first generic approv…

• FDA approval · 2006-07-19
  FDA Approved: MELOXICAM — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for MELOXICAM from Zydus Pharmaceuticals USA Inc., granting approval for a generic meloxicam product.

• FDA approval · 2006-07-19
  FDA Approved: MELOXICAM — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s generic meloxicam under an original ANDA; the approval covers the standard indications for meloxicam (osteoart…