Non-small Cell Lung Cancer

• FDA approval · 2018-08-22
  FDA Approved: IRESSA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for IRESSA (gefitinib) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2018-07-20
  FDA Approved: GEMCITABINE — Original Application (Sagent Pharmaceuticals)

  FDA approves Sagent Pharmaceuticals' original ANDA for gemcitabine, a generic injectable chemotherapy used to treat several cancers.

• FDA approval · 2018-07-02
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC. The generic is an i…

• FDA approval · 2018-06-05
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ALECENSA (alectinib hydrochloride) filed by Genentech, Inc., authorizing changes to its labe…

• FDA approval · 2018-04-30
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  The FDA approved Mylan Institutional LLC's original application for a generic docetaxel anhydrous product (ANDA208859).

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• FDA approval · 2018-04-18
  FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for Tagrisso (osimertinib) from AstraZeneca, resulting in changes to its approved labeling.

• FDA approval · 2018-04-17
  FDA Approved: ALIMTA — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2017-11-06
  FDA Approved: GILOTRIF — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GilotrIF (afatinib) filed by Boehringer Ingelheim Pharmaceuticals, Inc. The action appears t…

• FDA approval · 2017-11-06
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

  FDA has approved a supplemental application for Alecensa (alectinib hydrochloride) from Genentech, expanding its labeling.

• FDA approval · 2017-10-02
  FDA Approved: ALUNBRIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ALUNBRIG (brigatinib) from Takeda, resulting in updates to its labeling.

• FDA approval · 2017-09-14
  FDA Approved: MVASI — Original Application (Amgen, Inc)

  The FDA approved MVASI (bevacizumab-awwb) from Amgen as a biosimilar to Avastin, marking the original application granting U.S. approval for…

• FDA approval · 2017-08-09
  FDA Approved: DOCETAXEL — Original Application (Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

  FDA approved a generic version of docetaxel under an original ANDA from Jiangsu Hengrui Pharmaceuticals Co., Ltd., enabling market authoriza…

• FDA approval · 2017-08-03
  FDA Approved: GEMCITABINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's gemcitabine injectable drug as an original application, providing a generic version of the anticancer agent…

• FDA approval · 2017-07-21
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) filed by Pfizer, authorizing a change or addition to the drug’s labeling/in…

• FDA approval · 2017-06-22
  FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MEKINIST (trametinib) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2017-05-01
  FDA Approved: IMFINZI — Original Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved the original application for Imfinzi (durvalumab) from AstraZeneca, marking its first approved indication.

• FDA approval · 2017-04-28
  FDA Approved: ALUNBRIG — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves ALUNBRIG (brigatinib) under the original NDA for ALK-positive non-small cell lung cancer.

• FDA approval · 2017-04-28
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2017-03-17
  FDA Approved: CISPLATIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for cisplatin, a generic injectable chemotherapy agent (ANDA approval).

• FDA approval · 2017-01-24
  FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc. This notice confirms regul…

• FDA approval · 2017-01-19
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC.

• CLINICAL_TRIALS approval · 2016-11-30
  Clinical Trial Update: Afatinib Expanded Access Program

  Boehringer Ingelheim's Afatinib Expanded Access Program has been approved for marketing for non-small cell lung cancer.

• FDA approval · 2016-11-17
  FDA Approved: GEMCITABINE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for gemcitabine under ANDA 079183. This represents approval of a supplemental submissi…

• CLINICAL_TRIALS approval · 2016-11-10
  Clinical Trial Update: LUX Lung Special Access Scheme Australia Named Patient Use (NPU)

  Australia granted marketing approval for afatinib under the Special Access Scheme (Named Patient Use) for non-small cell lung cancer.

• FDA approval · 2016-11-04
  FDA Approved: ALECENSA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ALECENSA (alectinib hydrochloride) to update the label for its use in ALK-positive non-small…