Small Cell Lung Cancer

• FDA approval · 2015-09-28
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Topotecan Hydrochloride by Actavis Pharma, Inc., granting continued regulatory approval for this…

• FDA approval · 2015-06-02
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for HYCAMTIN (topotecan hydrochloride) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2014-02-28
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Hycamtin (topotecan hydrochloride) from Novartis Pharmaceuticals Corporation. The action likely …

• FDA approval · 2013-06-26
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's original application for a generic topotecan hydrochloride product.

• FDA approval · 2012-11-13
  FDA Approved: CISPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for cisplatin filed by Fresenius Kabi USA, LLC. This action confirms the continued approval of cispl…

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• FDA approval · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• FDA approval · 2011-10-07
  FDA Approved: HYCAMTIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for HYCAMTIN (topotecan) submitted by Sandoz Inc.

• FDA approval · 2011-08-26
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC, resulting in an updated regulatory status for the …

• FDA approval · 2010-12-02
  FDA Approved: TOPOTECAN HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Topotecan Hydrochloride from Actavis Pharma, Inc. as a generic cancer therapy.

• FDA approval · 2010-03-26
  FDA Approved: HYCAMTIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for HYCAMTIN (topotecan hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2008-09-05
  FDA Approved: HYCAMTIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Hycamtin (topotecan) submitted by Sandoz Inc.

• FDA approval · 2007-10-11
  FDA Approved: HYCAMTIN — Original Application (Sandoz Inc)

  FDA approved HYCAMTIN (topotecan) from Sandoz as the original application; the initial indications included treatment of relapsed small cell…