Pancreatic Cancer

• FDA approval · 2012-11-20
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) submitted by AbbVie Inc. The action involves modifications to the produ…

• 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.

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

  FDA approved the original ANDA for Fluorouracil by Eugia US LLC, enabling the marketing of a generic fluorouracil chemotherapy product.

• 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 · 2010-03-05
  FDA Approved: FLUOROURACIL — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved the original application for a generic fluorouracil product manufactured by Taro Pharmaceuticals U.S.A., Inc.

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• CLINICAL_TRIALS approval · 2009-06-15
  Clinical Trial Update: A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003

  The CONKO-003 Phase III trial in second-line therapy for advanced pancreatic cancer has resulted in regulatory approval for marketing.

• FDA approval · 2007-04-26
  FDA Approved: FLUOROURACIL — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare’s original application for Fluorouracil as a generic injectable chemotherapy agent for multiple cancers.

• FDA approval ·
  FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

  FDA approves Rasonque (daraxonrasib), a first-in-class RAS inhibitor, for metastatic pancreatic cancer, marking a novel targeted therapy opt…