FDAnews Marketing and Sales Bulletin

Amoxicillin-makers watch out. MiddleBrook Pharmaceuticals has received FDA approval for Moxatag once-daily, extended-release, 775-mg tablets for treating pharyngitis or tonsillitis secondary to Streptococcus pyogenes — also known as strep throat — in patients older than 12.

The approval was based on results from a Phase III clinical study conducted in more than 600 adult and adolescent patients that showed that once-daily treatment with Moxatag (amoxicillin) for 10 days was effective in eradicating strep throat. The drug also demonstrated statistical noninferiority to penicillin four times a day for 10 days. Furthermore, Moxatag was well tolerated, according to MiddleBrook.

Moxatag consists of three components — one immediate-release and two delayed-release — combined in a specific ratio to prolong the release of amoxicillin. MiddleBrook utilized its proprietary PULSYS once-daily pulsatile delivery technology to develop Moxatag.

Roughly 60 million prescriptions for amoxicillin — a quarter of which were for treating pharyngitis, tonsillitis and strep — were written in 2006, with sales exceeding $650 million, according to IMS Health. Amoxicillin is the drug most prescribed by pediatricians.