"Since receiving FDA approval for MOXATAG in January, we have been working closely with our contract manufacturer preparing for a potential commercial launch of MOXATAG by as early as the fourth quarter," stated Edward M. Rudnic, Ph.D., president and CEO of MiddleBrook. "Also, we intend to conclude our ongoing strategic process over the coming months."
Keflex(R) Capsules (Cephalexin, USP) - Commercialization Update
During the first quarter, MiddleBrook continued the commercialization of its 750 mg strength Keflex capsules through a targeted and dedicated national contract sales force. Based on prescription data from IMS Health, total prescriptions filled for Keflex 750 mg capsules in the first quarter of 2008 were 68,064 prescriptions, compared to fourth quarter 2007 prescriptions of 79,628.
MiddleBrook is currently marketing Keflex 750 mg capsules through its sales force of approximately 30 contract sales representatives and three MiddleBrook district sales managers.
MOXATAG(TM) (amoxicillin extended-release) Tablets Approval - January 23, 2008
On January 23, 2008, MiddleBrook received U.S. Food and Drug Administration (FDA) approval of the Company's New Drug Application (NDA) for its once-daily amoxicillin PULSYS(R) product, under the trade name, MOXATAG(TM) (amoxicillin extended-release) Tablets. MOXATAG is approved for the treatment of pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (strep throat) in adults and pediatric patients 12 years or older.
During the first quarter, MiddleBrook was actively engaged in the
commercial manufacture, testing and validation of its MOXATAG scaled-up
tablet production process in cooperation with its contract manufacturer,
STADA Production in Clonmel, Ireland. The Company believes it will be
prepared for a potential commercial launch of MOXATAG dur
|SOURCE MiddleBrook Pharmaceuticals, Inc.|
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