Pozen submits MT 100
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pozen initiates rolling NDA for migraine combination therapy MT 100 (metoclopramide/naproxen) July 31. At FDA's request, firm will submit a two-year rat carcinogenicity study in early 2004. Pozen is touting combo's similar efficacy and lower risk of cardiovascular side effects compared to triptans...