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MiddleBrook Pharmaceuticals Reports Third Quarter 2007 Results
Date:11/14/2007

to common stockholders during the first nine months of 2007 was ($0.78), down from a net loss per share of ($0.93) in the first nine months of 2006.

"We believe the Amoxicillin PULSYS NDA review process has progressed very well thus far and we look forward to continuing to work with the FDA throughout the remainder of their review," stated Edward M. Rudnic, Ph.D., president and CEO of MiddleBrook.

OPERATIONAL HIGHLIGHTS

Amoxicillin PULSYS NDA Review -- PDUFA Date January 23, 2008

On May 22, 2007, MiddleBrook's New Drug Application (NDA) for its once- daily Amoxicillin PULSYS product was accepted for filing by the U.S. Food and Drug Administration (FDA). MiddleBrook has worked closely with the FDA throughout the subsequent review process and anticipates a decision on the application on its Prescription Drug User Fee Act (PDUFA) target action date of January 23, 2008.

Amoxicillin is currently not approved for once-daily dosing to treat pharyngitis. If approved for marketing, physicians prescribing Amoxicillin PULSYS would have available the first once-daily product in the aminopenicillin class for the treatment of pharyngitis while utilizing approximately one-half the amount of amoxicillin currently used. About 15 million patients annually seek relief of sore throat symptoms in the United States.

Keflex(R) Capsules (Cephalexin, USP) -- Commercialization Update

During the third quarter, MiddleBrook continued the commercialization of its 750 mg strength Keflex capsules through a targeted and dedicated national contract sales force and MiddleBrook district sales managers. Based on prescription data from IMS Health, total prescriptions filled for Keflex 750 mg capsules in the third quarter of 2007 were 83,767 prescriptions, up from second quarter 2007 total prescriptions of 82,621.

MiddleBrook recently conducted a review of its Keflex sales initiatives and as a result reduced the size of its sales force to approximately 30 c
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SOURCE MiddleBrook Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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