FDA approves Moxatag antibiotic tablets

GERMANTOWN, Md. MiddleBrook Pharmaceuticals has received approval from the Food and Drug Administration for its application for a once daily antibiotic form of amoxicillin extended release tablets, called Moxatag 775mg tablets.

The drug is indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to strep throat.

The approval was based on the results from a phase III clinical study that showed the drug was just as likely to eradicate bacteria responsible for strep throat as a four-time daily dose of 250 mgs of penicillin over a 10-day course of treatment.

The company, in accordance with the agreement, has agreed to perform further tests on the drug for pediatric patients less than 12 years of age. Those results are expected within the next five years, according to the deal.