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Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results
Date:5/4/2011

everal milestones for Cumberland, including the FDA approval and launch of our new Acetadote formulation and an important shift in our sales strategy to drive broad use of Caldolor," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Our financial performance was strong, with net income more than doubling over the prior year period. We believe we are on track to meet our 2011 guidance and are well on our way to accomplishing our primary objectives for the year. We are also pleased to have announced the addition of Hepatoren, a new product candidate and the fourth in our portfolio, following the end of the first quarter."

First Quarter Highlights Caldolor

In June 2009, the U.S. Food and Drug Administration (FDA) approved Caldolor, the Company's intravenous formulation of ibuprofen, for marketing in the United States through a priority review. In September 2009, Cumberland implemented the U.S. launch of Caldolor with experienced sales professionals promoting the product across the country. Caldolor is stocked at wholesalers serving hospitals nationwide, available in both 400mg and 800mg vials.

In 2010, the Company focused its sales and marketing efforts primarily on securing formulary approval nationally for Caldolor, and the product is being stocked in a growing number of U.S. medical facilities. During the first quarter of 2011, Cumberland initiated a shift in focus to include pull-through activities necessary to build volume of use and help a larger population of patients in facilities already stocking the product.

Acetadote

FDA Approves New Formulation of Acetadote

In October 2010, the Company submitted a supplemental new drug application (sNDA) to the FDA for approval of a new formulation of Acetadote, which was the result of a phase IV commitment Cumberland made to the FDA upon receipt of initial marketing approval of the product. The new formulation addressed FDA safety concerns without
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SOURCE Cumberland Pharmaceuticals Inc.
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