Cumberland Pharmaceutical Inc. (NASDAQ: CPIX)
has
announced
that the U.S. Food and Drug Administration has approved expanded labeling for Caldolor, a formulation of ibuprofen, to include use in pre-operative administration. The FDA approved label includes information on the product’s indications and usage with appropriate patient populations, clinical study results, side effects, safety details and instructions for use in pregnant women, children and other populations. Dr. Stephen Southworth, an orthopedic surgeon at the Orthopedic Institute of North Mississippi concluded that “Caldolor® administered pre-operatively should be considered in Enhanced Recovery After Surgery (ERAS) protocols for the management of postoperative pain including that of traumatic origin. When administered immediately prior to surgery, patients given Caldolor experience less postoperative pain and a decrease in their opioid use.”
“Before the pandemic began, healthcare systems across the country were in the midst of a public health mission to control surgical pain while decreasing opioid consumption,” said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals Inc. “We are proud to see the continued support for Caldolor’s use in surgical care, with the product’s approved labeling now including the expanded use of the product prior to surgery. We feel confident that this important development provides additional insights into how intravenous ibuprofen can help healthcare professionals and patients as elective surgeries resume.”
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Cumberland Pharmaceuticals Reports FDA Approval for Caldolor
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Cumberland Pharmaceuticals Reports FDA Approval for Caldolor