Exocrine Pancreatic Insufficiency

• FDA approval · 2013-12-09
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

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

• 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.

• FDA approval · 2013-03-14
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for CREON (pancrelipase) by AbbVie.

• FDA approval · 2012-12-07
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  The FDA granted a supplemental approval for PANCREAZE (pancrelipase) to VIVUS LLC.

• 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…

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• FDA approval · 2012-05-17
  FDA Approved: PERTZYE — Original Application (Digestive Care, Inc.)

  PERTZYE (pancrelipase) was approved on an original application for the treatment of exocrine pancreatic insufficiency.

• FDA approval · 2012-03-01
  FDA Approved: VIOKACE — Original Application (Aimmune Therapeutics, Inc.)

  FDA approved Viokace (pancrelipase) via an original application from Aimmune Therapeutics, establishing a pancrelipase therapy for exocrine …

• FDA approval · 2011-07-13
  FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)

  The FDA approved a supplemental application for Zenpep (pancrelipase) submitted by Aimmune Therapeutics, authorizing changes to labeling rel…

• FDA approval · 2011-07-12
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie Inc., updating its labeling to reflect indications for exoc…

• FDA approval · 2011-06-20
  FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)

  FDA approved a supplemental application for PANCREAZE filed by VIVUS LLC.

• FDA approval · 2011-06-10
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie.

• FDA approval · 2010-08-12
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for CREON (pancrelipase) from AbbVie, updating its labeling/indication as part of a supplemental…

• FDA approval · 2010-04-30
  FDA Approved: CREON — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for CREON (pancrelipase) submitted by AbbVie.

• FDA approval · 2009-08-27
  FDA Approved: ZENPEP — Original Application (Aimmune Therapeutics, Inc.)

  FDA approves Zenpep (pancrelipase) in an Original Application for the treatment of exocrine pancreatic insufficiency due to conditions such …

• FDA approval · 2009-04-30
  FDA Approved: CREON — Original Application (AbbVie Inc.)

  FDA approved CREON (pancrelipase) under AbbVie’s original Biologics License Application, authorizing its marketing for exocrine pancreatic i…