Pancrelipase - Adare Pharmaceuticals

Drug Profile

Pancrelipase - Adare Pharmaceuticals

Alternative Names: Enzepi; EUR-1008; EUR-1008M; Pancrelipase delayed-release capsules - Adare Pharmaceuticals; Panzytrat; Ultrase; Ultrase MT; Ultresa; Viokace; Viokase; Zenpep; Zentase

Latest Information Update: 28 Feb 2017

Price : $50

At a glance

  • Originator Eurand
  • Developer Adare Pharmaceuticals
  • Class Pancreatic enzymes
  • Mechanism of Action Enzyme replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pancreatic disorders

Most Recent Events

  • 29 Apr 2016 The Committee for Medicinal Products for Human Use recommends approval of Pancrelipase for Pancreatic disorders (exocrine pancreatic insufficiency in patients with cystic fibrosis) in EU
  • 02 Apr 2015 Aptalis Pharmaceuticals has been acquired by TGP and renamed Adare Pharmaceuticals
  • 03 Feb 2014 Aptalis has been acquired by Forest Laboratories
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