A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

Trial Profile

A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Sep 2015

At a glance

  • Drugs Bendamustine (Primary)
  • Indications Cancer; Haematological malignancies; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Eagle Pharmaceuticals
  • Most Recent Events

    • 29 Sep 2015 According to an Eagle Pharmaceuticals media release, the Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA by the FDA is December 2015.
    • 14 Apr 2015 The NDA supported by data from this trial has been accepted for filing by the US FDA, and the goal date for a decision is Dec 2015, according to a media release from Teva Pharmaceutical Industries and Eagle Pharmaceuticals.
    • 17 Dec 2014 Primary endpoint has been met (bioequivalent area under the time concentration curve (AUC) for both drug products), according to an Eagle Pharmaceuticals media release.
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