Moxatag, an extended-release formulation of amoxicillin approved

The FDA has approved Moxatag (amoxicillin extended-release tablets, from MiddleBrook) 775mg for the treatment of patients ≥12 years of age with pharyngitis and/or tonsillitis due to Streptococcus pyogenes (Group A streptococcus). This approval is based on a double-blind trial involving >600 patients that showed once-daily Moxatag was effective in eradicating S. pyogenes and demonstrated statistical non-inferiority compared to a four times daily dose of penicillin.

Moxatag consists of one immediate-release and two delayed-release amoxicillin components designed to prolong the release of amoxicillin as compared to the immediate-release formulations.

For more information call (301) 944-6600 or visit www.middlebrookpharma.com.