FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents ...( Amoxicillin PULSYS to be Marketed...),Health

Amoxicillin PULSYS to be Marketed as MOXATAG(TM) - First Once-Daily

Amoxicillin Product Approved in U.S.

GERMANTOWN, Md., Jan. 24 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received approval of its New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), for its once-daily MOXATAG(TM) Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

The FDA approval was based on results from a Phase 3 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.

"We are extremely gratified to have received FDA approval of our MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe MOXATAG represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."

In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further
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