Cumberland Pharmaceuticals gets FDA approval for expanded Caldolor indication

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) announced it received U.S. Food and Drug Administration approval for an expanded indication for its Caldolor (ibuprofen) injection product. The indication now includes management of postoperative pain, according to a company statement.

Caldolor is now indicated for use in adult and pediatric patients ages 3 months and older for management of mild to moderate pain, including postoperative pain; management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics; and reduction of fever.

The Nashville-based specialty pharmaceutical company also launched a new website for healthcare professionals highlighting the expanded indication and non-opioid pain management approaches. The website provides resources on intravenous non-opioid options in perioperative care, opioid stewardship strategies, and clinical data supporting Caldolor's safety and efficacy.

Caldolor was the first FDA-approved intravenous therapy for fever. The drug is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs and those with a history of asthma or allergic reactions to aspirin or other NSAIDs. It is also contraindicated for use during the peri-operative period in coronary artery bypass graft surgery.

Cumberland Pharmaceuticals describes itself as the largest biopharmaceutical company founded and headquartered in Tennessee. The company's portfolio includes seven FDA-approved brands for hospital acute care, gastroenterology and oncology market segments, including Acetadote, Kristalose, Sancuso, Vaprisol, Vibativ and Talicia.

You May Also Be Interested In

• FDA clears Dexcom's over-the-counter glucose monitor for children
• 22nd Century Group files prospectus for warrant share resale
• Venu Holding enters $250 million at-the-market stock offering agreement