Non-small Cell Lung Cancer

• FDA approval · 2013-01-09
  FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Vinorelbine submitted by Sagent Pharmaceuticals, making a generic version of the cancer drug ava…

• 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…

• FDA approval · 2012-09-26
  FDA Approved: VINORELBINE — Original Application (Sagent Pharmaceuticals)

  FDA approved the original ANDA for vinorelbine (VINORELBINE) from Sagent Pharmaceuticals.

• 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 · 2012-02-17
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental NDA (NDA 202570) for XALKORI (crizotinib) from Pfizer Laboratories Div Pfizer Inc.

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• FDA approval · 2011-11-18
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.

• FDA approval · 2011-08-26
  FDA Approved: XALKORI — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved XALKORI (crizotinib) through an original application by Pfizer Laboratories Div Pfizer Inc. This marks the initial FDA approval…

• 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 · 2011-07-25
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Original Application (Teyro Labs Private Limited)

  The FDA approved an original ANDA for gemcitabine hydrochloride from Teyro Labs Private Limited, enabling its generic use.

• FDA approval · 2011-06-29
  FDA Approved: DOCETAXEL — Original Application (Baxter Healthcare Corporation)

  FDA approved the original application for docetaxel by Baxter Healthcare Corporation, marking its initial U.S. approval as a cancer therapy.…

• FDA approval · 2010-05-26
  FDA Approved: VINORELBINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Vinorelbine from Actavis Pharma, Inc., indicating an update to its labeling/indications.

• FDA approval · 2006-07-28
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ALIMTA (pemetrexed disodium) submitted by Eli Lilly and Company.