Gastric Cancer

• FDA approval · 2018-12-14
  FDA Approved: HERZUMA — Original Application (Cephalon, Inc.)

  FDA approved Herzuma (trastuzumab) through an original Biologics License Application, establishing it as a biosimilar to trastuzumab for ind…

• FDA approval · 2018-12-06
  FDA Approved: TYKERB — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tykerb (lapatinib) from Novartis Pharmaceuticals Corporation, approving an additional indication…

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

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

• FDA approval · 2017-12-01
  FDA Approved: OGIVRI — Original Application (Biocon Biologics Inc.)

  The FDA approved OGIVRI (trastuzumab-dkst) from Biocon Biologics as a biosimilar to trastuzumab through Biocon's Original Application. It is…

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• 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 · 2017-04-27
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for HERCEPTIN (trastuzumab) submitted by Genentech, Inc. The action pertains to a supplemental appro…

• FDA approval · 2017-03-30
  FDA Approved: LONSURF — Supplemental Application (Taiho Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for LONSURF (trifluridine and tipiracil) from Taiho Pharmaceutical, expanding its regulatory coverag…

• FDA approval · 2017-03-27
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for HERCEPTIN (trastuzumab) submitted by Genentech, Inc.

• FDA approval · 2017-01-06
  FDA Approved: FLUOROURACIL — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Fluorouracil from Fresenius Kabi USA, LLC.

• FDA approval · 2016-12-27
  FDA Approved: FLUOROURACIL — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Fluorouracil (5-fluorouracil) from Eugia US LLC.

• FDA approval · 2016-12-14
  FDA Approved: FLUOROURACIL — Supplemental Application (Eugia US LLC)

  The FDA has approved a supplemental application for Fluorouracil from Eugia US LLC, formalizing an update to the product under the ANDA path…

• FDA approval · 2016-08-23
  FDA Approved: PACLITAXEL PACLITAXEL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved the original application for a generic paclitaxel product, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac…

• FDA approval · 2016-04-04
  FDA Approved: CAPECITABINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for CAPECITABINE submitted by BluePoint Laboratories. The action concerns the generic capecitabi…

• FDA approval · 2016-02-18
  FDA Approved: CAPECITABINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for capecitabine filed by Teva Pharmaceuticals USA, Inc. (ANDA 091649).

• FDA approval · 2015-08-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Mylan Pharmaceuticals, resulting in an updated regulatory status for t…

• FDA approval · 2015-05-04
  FDA Approved: OXALIPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for a generic Oxaliplatin product from Fresenius Kabi USA, LLC. This approval permits marketing of t…

• FDA approval · 2014-12-05
  FDA Approved: CAPECITABINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Capecitabine from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2014-11-05
  FDA Approved: DOCETAXEL — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves the original (ANDA) application for docetaxel generic produced by Dr. Reddy's Laboratories.

• FDA approval · 2014-07-10
  FDA Approved: DOCETAXEL — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for Docetaxel.

• FDA approval · 2014-06-30
  FDA Approved: HERCEPTIN — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Herceptin (trastuzumab) submitted by Genentech, Inc. The action updates the product's labeli…

• FDA approval · 2014-05-15
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Docetaxel (Sanofi-Aventis U.S. LLC), indicating an approved modification to its labeling and…

• FDA approval · 2014-04-21
  FDA Approved: CYRAMZA — Original Application (Eli Lilly and Company)

  The FDA approved the original application for ramucirumab (CYRAMZA) by Eli Lilly for metastatic gastric or gastroesophageal junction adenoca…

• FDA approval · 2013-09-16
  FDA Approved: CAPECITABINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Capecitabine as an original application for Teva Pharmaceuticals USA, confirming a generic version of the chemotherapy agent.

• FDA approval · 2012-07-17
  FDA Approved: FLUOROURACIL — Original Application (Eugia US LLC)

  FDA-approved the original ANDA for fluorouracil from Eugia US LLC, granting a generic version of fluorouracil for cancer chemotherapy.