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Cumberland Pharmaceuticals Reports 2012 Annual Financial Results
Date:2/28/2013

y receives final approval from the FDA for an ANDA to sell a generic Acetadote product and such third party has made such generic version available for purchase in commercial quantities in the United States, the Company will supply Perrigo with an authorized generic version of the Company's Acetadote product.

In January 2013, Perrigo announced initial distribution of Cumberland's authorized generic acetylcysteine injection product.

Caldolor®

Cumberland is pleased to announce new top-line results from a pilot clinical study evaluating the safety and analgesic efficacy of Caldolor (ibuprofen) Injection compared to ketorolac injection in treating pain following knee arthroscopy procedures in adult patients.

Fifty-one patients were enrolled at The Ohio State Medical Center. Compared to patients receiving ketorolac, patients receiving intravenous ibuprofen experienced less postoperative pain prior to discharge. Patients receiving Caldolor also needed fewer narcotics and were less likely to require narcotics prior to discharge. This data supports the benefits of using Caldolor in a pre-emptive model of multimodal analgesia.

These positive results follow the February release of two recent studies affirming the safety and efficacy of Caldolor in treating pain and fever in adult patients when administered over a shortened infusion time. Top-line results from these two registry studies involved 450 patients who received Caldolor at 34 leading medical centers throughout the United States.

The Company continued to expand the international market for Caldolor through strategic partnerships. In December 2012, the application for regulatory approval of Caldolor for fever in Australia by Cumberland's partner Phebra Pty Ltd., was approved.

In January 2013, Cumberland entered into agreements with India's Sandor Medicaids Pvt. Ltd. and Indonesia's PT. SOHO Industri Pharmasi (a SOHO Group company) for the commerci
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SOURCE Cumberland Pharmaceuticals Inc.
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