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news.Advancis Pharmaceutical has filed a new drug application with the FDA, for its once-daily Amoxicillin Pulsys for the treatment of adolescents and adults with strep throat.
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Amoxicillin Pulsys has previously faced setbacks when the drug failed clinical trials. However a recent phase III trial of Amoxicillin Pulsys successfully met its primary and secondary endpoints. The drug is the first product to near marketing approval using Advancis’ Pulsys technology, The drug is the first product to near marketing approval using Advancis’ Pulsys technology, which provides a lower treatment dose, once-daily alternative to current approved penicillin and amoxicillin regimens.
“We believe Amoxicillin Pulsys would offer physicians and patients a major advance in the most commonly prescribed antibiotic in the US,” said Dr Edward Rudnic, Advancis president and CEO.
The FDA is expected to determine within 60 days whether the submission is acceptable for filing.