FDA REJECTS ADVANCIS' NDA FOR ONCE-DAILY AMOXICILLIN

Advancis Pharmaceutical announced that it has received a refusal-to-file letter from the FDA for its once-daily amoxicillin PULSYS new drug application (NDA). The letter requests additional information on the company's planned commercial manufacturing processes.

Advancis submitted the NDA for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with acute pharyngitis/tonsillitis in December 2006 via the 505(b)(2) regulatory pathway. In accordance with FDA guidelines, the agency has 60 days to review the NDA filing and assess whether the application is acceptable for filing and substantive review, according to the company.

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 intends to meet with the FDA to discuss the issues raised and to reach agreement on what additional information is required for the filing to be accepted. The agency did not raise any clinical or other issues, according to the company.