RxTrials Institute Drug Pipeline Alert

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.