Advancis to file NDA for strep throat drug Pulsys

By Lisa Kerner

Charlotte, N.C., Sept. 13 - The Food and Drug Administration approved Advancis Pharmaceutical Corp.'s regulatory strategy and proposed format for a New Drug Application filing for its once-daily Amoxicillin Pulsys product for pharyngitis/tonsillitis due to streptococcal infections (strep throat).

"Based on the feedback we received from the FDA yesterday, we have reached agreement that data in-hand and the results of our just-concluded phase 3 trial will be sufficient to support an NDA filing for Amoxicillin Pulsys for adults and adolescents with strep throat around year-end," president Edward Rudnic said in a company news release.

Roughly 60 million prescriptions for amoxicillin were written in 2005 for a broad range of infections including otitis media and sinusitis.

Advancis is a pharmaceutical company based in Germantown, Md.

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