Advancis Pharmaceutical Corporation, a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with pharyngitis/tonsillitis (commonly referred to as strep throat) via the 505(b)(2) regulatory pathway.

"We are very pleased with the timely achievement of this significant milestone for Advancis," said Dr. Edward Rudnic, Advancis president and CEO. "We are proud to have completed our first NDA for a proprietary PULSYS product, and if approved, we believe Amoxicillin PULSYS would offer physicians and patients a major advance in the most commonly prescribed antibiotic in the United States. I am very proud of our R&D team for this tremendous accomplishment."

The FDA is expected to determine within 60 days whether the submission is acceptable for filing. Should the FDA accept the application for filing, the Company expects to receive a Prescription Drug User Fee Act (PDUFA) action date of 10 months from the date of filing.

On August 10, 2006, Advancis announced that the Company's Phase III trial for the treatment of acute pharyngitis/tonsillitis in 620 adults and adolescent patients due to Group A streptococcal infections successfully met its primary and secondary endpoints. The Company's Amoxicillin PULSYS dosage form for the treatment of pharyngitis was delivered in a once-daily 775 milligram tablet for 10 days, versus the standard comparator therapy of 250 milligrams of penicillin VK dosed four times daily, for a total of one gram per day, for 10 days.

In September 2006, Advancis received correspondence from the FDA's Division of Anti-Infectives Drug Products, confirming that the regulatory strategy and proposed format for Advancis' NDA filing for its once-daily Amoxicillin PULSYS product was acceptable. The FDA indicated that Advancis' recently concluded Phase III clinical trial in adults and adolescents, along with the Company's Phase I pharmacokinetic studies, results from the Company's prior adult and adolescent Amoxicillin PULSYS Phase III trial, and existing academic literature would be sufficient to support an NDA filing.

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