Rheumatoid Arthritis

• 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 · 2007-03-28
  FDA Approved: NAPROXEN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's naproxen generic under an original ANDA, enabling market access for generic naproxen products.

• FDA approval · 2007-03-16
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for nabumetone by Chartwell RX, LLC, indicating an additional authorization for this generic drug un…

• 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…

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• FDA approval · 2006-12-19
  FDA Approved: DG HEALTH NAPROXEN SODIUM — Supplemental Application (Dolgencorp Inc)

  FDA approved a supplemental application for DG Health Naproxen Sodium (naproxen sodium) by Dolgencorp Inc. The action approves the generic p…

• 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 · 2006-11-17
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for Etodolac from Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2006-11-17
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for etodolac (generic) submitted by Taro Pharmaceuticals U.S.A., Inc., indicating a supplemental app…

• 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 · 2006-08-08
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

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

• 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…

• FDA approval · 2006-06-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to market a generic cyclosporine product.

• FDA approval · 2006-05-16
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for an ibuprofen product manufactured by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2006-05-08
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for cyclosporine (Apotex Corp.) under an ANDA, indicating approval of a supplemental update to this …