Cumberland Pharmaceuticals Receives FDA Approval for Expanded Caldolor Indication in Postoperative Pain Management
Key Insights
Cumberland Pharmaceuticals (search) received FDA approval for an expanded indication for Caldolor (ibuprofen) injection to include management of postoperative pain (search) in adult and pediatric patients ages 3 months and older.
The approval reinforces Caldolor's role as a versatile, non-opioid intravenous analgesic option for perioperative and acute care settings amid growing emphasis on opioid-sparing approaches.
Cumberland launched a new website highlighting the expanded indication and providing healthcare professionals with resources on multimodal pain management strategies and opioid stewardship.
Cumberland Pharmaceuticals (search) Inc. announced it has received approval from the US Food and Drug Administration (FDA) for an expanded indication for its Caldolor (ibuprofen) injection product. The indication now includes the management of postoperative pain (search), marking a significant advancement in non-opioid pain management options for healthcare providers.
Expanded Clinical Applications
With this update, Caldolor is 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
- Reduction of fever
This expanded labeling reinforces Caldolor's role as a versatile, non-opioid intravenous analgesic option for use in perioperative and acute care settings. Caldolor was the first FDA-approved intravenous therapy for fever (search).
Addressing Postoperative Pain Challenges
Postoperative pain (search) remains a significant challenge across surgical settings, with a growing emphasis on reducing opioid exposure while maintaining effective pain control. The approval comes at a time when healthcare providers are increasingly seeking opioid-sparing approaches amid the ongoing opioid crisis.
Cumberland has launched a newly designed website for healthcare professionals that aligns with this expanded indication, featuring dedicated content on postoperative pain (search) management and the importance of multimodal, opioid-sparing approaches. The updated website provides healthcare professionals with resources that focus on:
- The role of IV non-opioid options like Caldolor in perioperative care
- Strategies to support opioid stewardship amid the ongoing opioid crisis
- Clinical data supporting safe and effective pain and fever management with Caldolor
Safety Profile and Contraindications
Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) and patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. The medication is also contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
Company Background
Cumberland Pharmaceuticals (search) Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments.
The website reinforces Caldolor as "A Safe and Effective Non-Opioid Pain Management Solution" and offers comprehensive information on safety, dosing, efficacy, and access with J-Code reimbursement support.