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news.Advancis Pharmaceutical has said that is has agreed with the FDA to submit additional data on its manufacturing processes for its Amoxicillin PULSYS product in order to gain its approval for treatment of strep throat.
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In February 2007, Advancis received a “refusal to file” letter from the FDA for its once-daily Amoxicillin PULSYS new drug application.
In its letter, the FDA indicated that Advancis' application was not sufficiently complete in that it did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls.
Advancis believes it will be in a position to resubmit its new drug application in March 2007.
Should the FDA accept the application for filing, the company expects to receive a Prescription Drug User Fee Act action date about January 2008. If approved in January 2008, Advancis anticipates commercial launch of Amoxicillin PULSYS in late February 2008.