Acetylcysteine injection - Cumberland Pharmaceuticals

Drug Profile

Acetylcysteine injection - Cumberland Pharmaceuticals

Alternative Names: N-acetylcysteine (NAC) injection - Cumberland Pharmaceuticals; Acetadote; Intravenous NAC - Cumberland Pharmaceuticals

Latest Information Update: 11 Sep 2017

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At a glance

  • Originator Cumberland Pharmaceuticals
  • Developer Al-Nabil; Cumberland Pharmaceuticals; GerminMED; Harbin Gloria Pharmaceuticals
  • Class Antibronchitics; Antidotes; Expectorants; Reducing agents; Small molecules; Sulfur amino acids
  • Mechanism of Action Antioxidants; Free radical inhibitors
  • Orphan Drug Status

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

    Yes - Poisoning
  • New Molecular Entity No

Highest Development Phases

  • Marketed Poisoning
  • Discontinued Kidney disorders; Liver failure

Most Recent Events

  • 11 Sep 2017 Discontinued - Preregistration for Liver failure in USA (IV), because no recent reports identified after the US FDA issued a complete response letter
  • 11 Sep 2017 No recent reports on development identified - Preregistration for Poisoning in United Arab Emirates, Saudi Arabia and Qatar (IV)
  • 13 Mar 2017 Clinical development for Poisoning is ongoing in China (IV) (Cumberland Pharmaceuticals 10-K, March 2017)
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