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news.MiddleBrook Pharmaceuticals has received approval of its new drug application from the FDA, for its once-daily Moxatag tablets 775mg for the treatment of adults and pediatric patients 12 years and older with pharyngitis or tonsillitis secondary to Streptococcus pyogenes.
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The FDA approval was based on results from a Phase III clinical study conducted with more than 600 patients that found once-daily Moxatag for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. Moxatag was very well tolerated in the clinical trial.
In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further evaluate its Moxatag product candidate for pediatric patients less than 12 years of age with pharyngitis or tonsillitis as part of a post-marketing commitment. The company has agreed to submit a completed study report and data set for Moxatag in pediatric patients less than 12 years old within the next five years as part of this commitment.
Edward Rudnic, president and CEO of MiddleBrook, said: “As the first and only once-daily amoxicillin therapy approved for marketing in the US, we believe Moxatag represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat.”