Rheumatoid Arthritis

• 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 · 2011-10-28
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Leflunomide from Apotex Corp.

• 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 · 2011-09-07
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for SIMPONI (golimumab) filed by Janssen Biotech, Inc.

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• FDA approval · 2011-08-29
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Leflunomide (generic) submitted by Chartwell RX, LLC under an ANDA, enabling market authorizatio…

• 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 · 2011-06-13
  FDA Approved: NABUMETONE — Original Application (Actavis Pharma, Inc.)

  FDA approves the original application for Nabumetone as a generic (ANDA) drug manufactured by Actavis Pharma, Inc.

• FDA approval · 2011-04-29
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for Leflunomide (generic). This confirms an approved change under the Abbreviated New D…

• FDA approval · 2011-04-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for METHOTREXATE from Hikma Pharmaceuticals USA Inc., granting a supplemental approval for the g…

• FDA approval · 2011-04-12
  FDA Approved: INDOMETHACIN — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approved the Indomethacin Original Application for XLCare Pharmaceuticals Inc., enabling a generic indomethacin product to reach the mar…

• FDA approval · 2011-03-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., under an existing ANDA. This action confirms the…

• 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 · 2011-01-20
  FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  FDA approved a supplemental application submitted by Sunrise Pharmaceutical, Inc. under ANDA040349 to market a generic form of sulfasalazine…

• FDA approval · 2011-01-12
  FDA Approved: NABUMETONE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic Nabumetone (Nabumetone) original application, enabling its use for relief of pain and inflam…

• 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 · 2010-12-01
  FDA Approved: DICLOFENAC SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for Diclofenac Sodium (generic diclofenac) from Rising Pharma Holdings, Inc., providing a generic diclofenac …

• 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 · 2010-09-09
  FDA Approved: ARAVA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for ARAVA (leflunomide) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2010-08-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium submitted by Bionpharma Inc.

• 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 · 2010-07-29
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc., resulting in an approved amendment to it…