Juvenile Idiopathic Arthritis

• FDA approval · 2013-02-07
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new dosage form for the Aleve product line, expanding th…

• FDA approval · 2012-12-10
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation.

• FDA approval · 2012-12-04
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2012-09-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2012-09-28
  FDA Approved: INDOMETHACIN — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' indomethacin as an original ANDA (generic) application, making Indomethacin available as a generic …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2012-05-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2012-03-05
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  FDA approved a supplemental application for ZYBIC (meloxicam) submitted by Redmont Pharmaceuticals, LLC.

• FDA approval · 2011-12-26
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2011-12-13
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.

• FDA approval · 2011-10-31
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Meloxicam from Aurobindo Pharma Limited. This approval updates the approved product under th…

• FDA approval · 2011-09-19
  FDA Approved: NAPROXEN — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Naproxen under Original Application, making a generic naproxen product available. It is used to relieve pain a…

• FDA approval · 2011-09-07
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Cimzia (certolizumab pegol) submitted by UCB, Inc. This action approves the changes described in…

• FDA approval · 2011-08-24
  FDA Approved: NAPROXEN — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved Exelan Pharmaceuticals' original ANDA for Naproxen (generic naproxen). This confirms a generic naproxen product for arthrit…

• FDA approval · 2011-08-18
  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.

• FDA approval · 2011-02-17
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., signaling a labeling update or expansion of its appro…

• FDA approval · 2010-12-28
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved Janssen Biotech, Inc.'s supplemental application for infliximab. The approval updates the product's labeling and indications as…

• FDA approval · 2010-12-10
  FDA Approved: IBUPROFEN — Original Application (Dolgencorp, Inc.)

  FDA approved Dolgencorp, Inc.'s ibuprofen 200 mg tablets as an original generic application (ANDA). The approval supports OTC use for relief…

• FDA approval · 2010-10-26
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Zydus Pharmaceuticals USA Inc., resulting in changes to the labeling.…

• FDA approval · 2010-07-29
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA has approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.

• FDA approval · 2010-07-29
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  FDA approved a supplemental application for ZYBIC (meloxicam) from Redmont Pharmaceuticals, LLC. The action pertains to a supplemental appro…

• FDA approval · 2010-06-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2010-04-26
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  FDA approved a supplemental application for ZYBIC (meloxicam) submitted by Redmont Pharmaceuticals, LLC.

• FDA approval · 2009-09-24
  FDA Approved: MELOXICAM — Supplemental Application (Carlsbad Technology, Inc.)

  The FDA approved a supplemental application for Meloxicam from Carlsbad Technology, Inc., indicating the supplemental action for the generic…

• FDA approval · 2009-05-13
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc.

• FDA approval · 2008-07-31
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for Tolmetin Sodium from Atland Pharmaceuticals, LLC.