Pancreatic Cancer

• FDA approval · 2020-10-06
  FDA Approved: GEMCITABINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for gemcitabine from Fresenius Kabi USA, approving a generic gemcitabine product under ANDA 090799. …

• FDA approval · 2020-04-16
  FDA Approved: ERLOTINIB — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic erlotinib product from Zydus Lifesciences Limited under an original ANDA submission.

• FDA approval · 2020-03-20
  FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)

  FDA approved a supplemental application for Viokace (pancrelipase) by Aimmune Therapeutics, expanding its labeling for exocrine pancreatic i…

• FDA approval · 2019-12-27
  FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP. The approval updates the product labeli…

• FDA approval · 2019-11-05
  FDA Approved: ERLOTINIB — Original Application (Armas Pharmaceuticals Inc.)

  The FDA approved Armas Pharmaceuticals' original application (ANDA211960) for erlotinib hydrochloride as a generic version of erlotinib, for…

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• FDA approval · 2019-11-05
  FDA Approved: ERLOTINIB — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic Erlotinib (ERLOTINIB) under an Original Application (ANDA), providing a generic option f…

• FDA approval · 2019-10-03
  FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for gemcitabine hydrochloride from Gland Pharma Limited. This approval enables the marketing of …

• FDA approval · 2019-03-13
  FDA Approved: DOCETAXEL ANHYDROUS — Supplemental Application (Meitheal Pharmaceuticals Inc)

  The FDA approved a supplemental application from Meitheal Pharmaceuticals to market docetaxel anhydrous as a generic chemotherapy drug.

• 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 · 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 · 2017-01-06
  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 · 2016-11-17
  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…

• FDA approval · 2016-10-06
  FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)

  FDA Supplemental Application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc. under BLA022175. The submission pertains to a supp…

• 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 · 2016-05-16
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for Pancreaze (pancrelipase) by VIVUS LLC, expanding labeling/indications related to exocrine pancre…

• FDA approval · 2016-05-03
  FDA Approved: IRINOTECAN HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s Original Application for irinotecan hydrochloride, establishing a generic version of irinotecan for cancer treat…

• FDA approval · 2016-02-17
  FDA Approved: FLUOROURACIL — Original Application (Sagent Pharmaceuticals)

  FDA approves an Original Application for Fluorouracil from Sagent Pharmaceuticals, establishing a generic injectable form of the chemotherap…

• FDA approval · 2016-01-26
  FDA Approved: GEMCITABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' supplemental application for gemcitabine hydrochloride (gemcitabine), enabling continued producti…

• FDA approval · 2015-10-22
  FDA Approved: ONIVYDE — Original Application (Ipsen Biopharmaceuticals, Inc.)

  FDA approved ONIVYDE (irinotecan hydrochloride liposome injection) under the Original Application from Ipsen Biopharmaceuticals, Inc., for p…

• FDA approval · 2015-08-28
  FDA Approved: ERLOTINIB — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's erlotinib original application, making a generic version available for the same uses as the reference product. The appro…

• 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…

• EMA approval · 2013-11-22
  European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer

  The EMA recommends extending the use of Abraxane to include treatment of pancreatic cancer, potentially expanding its approved indications.

• FDA approval · 2013-04-11
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics.