GERMANTOWN, Md., Feb. 28 (UPI) -- Advancis said Wednesday it reached a deal with the U.S. Food and Drug Administration to refile its application for Amoxicillin PULSYS.
On Feb. 12 Advancis received a "refusal to file" letter from the FDA requesting additional information on its commercial manufacturing processes for Amoxicillin PULSYS, a once-daily treatment for strep throat.
Advancis said it held a meeting with the FDA this week at which it agreed to provide the additional information and now believes it will be in a position to resubmit the new drug application in March.
"With this additional clarity, we will be working diligently to gather the required information and resubmit our NDA as soon as possible," said Edward Rudnic, Advancis' president and chief executive officer. "We expect this process will take approximately two weeks, allowing us to resubmit our NDA in March."
If the FDA accepts the NDA, Advancis anticipates an FDA decision on the drug by January 2008.
