Immune Thrombocytopenia

• FDA approval · 2017-03-09
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) by Novartis Pharmaceuticals Corporation. The action updates the p…

• FDA approval · 2015-08-24
  FDA Approved: PROMACTA — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved PROMACTA (eltrombopag olamine) in its original application for the treatment of immune thrombocytopenia. This represents the in…

• FDA approval · 2014-08-26
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2014-02-10
  FDA Approved: PROMACTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for PROMACTA (eltrombopag olamine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2013-05-30
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) from Amgen, Inc.

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• FDA approval · 2012-11-02
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NPLATE (romiplostim) from Amgen, approving an update to the product's labeling and/or indication…

• FDA approval · 2011-12-06
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for NPLATE (romiplostim), resulting in updated labeling.

• FDA approval · 2011-06-21
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) from Amgen.

• FDA approval · 2010-03-23
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NPLATE (romiplostim) submitted by Amgen, Inc.

• FDA approval · 2009-09-18
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) from Amgen, Inc.

• FDA approval · 2009-08-14
  FDA Approved: NPLATE — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NPLATE (romiplostim) submitted by Amgen, Inc. The notice does not specify new indications or…

• FDA approval · 2008-11-20
  FDA Approved: PROMACTA — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved PROMACTA (eltrombopag olamine) under the original NDA for treatment of adults with chronic immune thrombocytopenia who have had…

• FDA approval · 2008-08-22
  FDA Approved: NPLATE — Original Application (Amgen, Inc)

  FDA approved NPLATE (romiplostim) under the original biologics license application for the treatment of chronic immune thrombocytopenia.