A phase III multicenter study to evaluate the safety/efficacy of APC-111 MP [amoxicillin multi particulate] tablet qd vs. penicillin VK [phenoxymethylpenicillin potassium] qid both for 10 days treatment of pharyngitis secondary to S. pyogenes in adolescents/adults
Phase of Trial: Phase III
Latest Information Update: 24 Jan 2008
At a glance
- Drugs Amoxicillin; Phenoxymethylpenicillin potassium
- Indications Pharyngitis; Streptococcal infections; Tonsillitis
- Focus Registrational; Therapeutic Use
- Sponsors MiddleBrook Pharmaceuticals
- 24 Jan 2008 Based on the results from this study, an NDA for the once-daily 775mg extended-release formulation (Moxatag) for adolescents and adults has been approved by the US FDA.
- 26 Nov 2005 New trial record.