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