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Budesonide gastro-resistant granules - Dr Falk Pharma

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Drug Profile

Budesonide gastro-resistant granules - Dr Falk Pharma

Alternative Names: Budenofalk Granules; Budo-San; Intestifalk

Latest Information Update: 27 Sep 2022

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At a glance

  • Originator Dr Falk Pharma
  • Developer Dr Falk Pharma; Merck & Co
  • Class Alcohols; Anti-inflammatories; Antiallergics; Antiasthmatics; Antivirals; Dioxoles; Glucocorticoids; Pregnenediones; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Crohn's disease; Microscopic colitis
  • Phase III Ulcerative colitis

Most Recent Events

  • 27 Sep 2022 No development reported - Phase-III for Microscopic colitis in Italy (PO)
  • 12 Aug 2019 Budesonide (Budenofalk) licensed to Calliditas Therapeutics in USA
  • 12 Aug 2019 Calliditas Therapeutics plans a meeting with the FDA to decide regulatory path for development in Autoimmune hepatitis in the first quarter of 2020

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