Pivotal bioequivalence trial of ELI 200 vs branded formulation.
Phase of Trial: Phase I
Latest Information Update: 15 Jul 2016
At a glance
- Drugs ELI 200 (Primary) ; Opioid analgesics
- Indications Pain
- Focus Pharmacokinetics; Registrational
- Sponsors Elite Pharmaceuticals
- 15 Jul 2016 According to Elite Pharmaceuticals media release, the U.S. Food and Drug Administration (the "FDA") has issued a Complete Response Letter (the "CRL") regarding the New Drug Application (the "NDA") for SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride). The CRL determined that the NDA was not ready for approval in its present form.
- 09 May 2016 According to an Elite Pharmaceuticals media release, the New Drug Application (NDA) for ELI-200 (SequestOX) has been accepted and granted priority review by the FDA with target action date under the Prescription Drug User Fee Act (PDUFA) of July 14, 2016.
- 09 Feb 2016 Elite Pharmaceuticals has submitted a 505(b)(2) NDA to the US FDA, according to a company media release.