www.fdanews.com/articles/102288-proethic-8217-s-migraine-application-accepted-by-fda
ProEthic’s Migraine Application Accepted by FDA
December 14, 2007
The FDA has accepted ProEthic’s new drug application for PRO-513, a treatment for migraine headaches.
The FDA has set the Prescription Drug User Fee Act date as July 27, 2008.
PRO-513 utilizes ProEthic’s dynamic buffering technology, which enables the active ingredient diclofenac to enter at a faster rate while not increasing drug exposure when compared with Cataflam, the marketed reference drug, ProEthic said.