Cumberland Pharmaceuticals Stock Skyrockets After FDA Approved Caldolor® For Pre-Operative Administration

Nov 30, 2021 By MarketDepth

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FDA Approval

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) shares jumped more than 100% after the Company announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration. The non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain.

Label Information

The Nashville based pharmaceutical Company indicated that the newly FDA-approved label includes information regarding the product’s indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in pregnant women, children and other populations.

“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. 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.”

A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals Inc.

Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, focuses on the acquisition, development, and commercialization of prescription products for hospital acute care, gastroenterology, and rheumatology in the United States and internationally.