Cumberland Pharmaceuticals Announces Expanded Indication for Caldolor (ibuprofen) Injection

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NASHVILLE, Tenn., April 16, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its Caldolor (ibuprofen) Injection product. The indication now includes the management of postoperative pain, and the approval coincides with the launch of a newly designed website for healthcare professionals highlighting this advancement and the evolving role of non-opioid pain management.

  • A Safe and Effective Non-Opioid Pain Management Solution

    • 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.

    Advancing Perioperative Pain Management

    The newly launched Caldolor website aligns with this expanded indication, featuring dedicated content on postoperative pain management and the importance of multimodal, opioid-sparing approaches.

    Postoperative pain remains a significant challenge across surgical setting, with a growing emphasis on reducing opioid exposure while maintaining effective pain control. 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

    • In addition to featuring the new postoperative pain indication, the website offers comprehensive information on safety, dosing, efficacy, and access with J-Code reimbursement support.

    About Caldolor® (ibuprofen) InjectionCaldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain, including postoperative pain management, as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. 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. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.

    About Cumberland PharmaceuticalsCumberland Pharmaceuticals 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 company's portfolio of FDA-approved brands includes:

  • Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
  • Caldolor® (ibuprofen) injection, for the treatment of pain and fever;
  • Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation;
  • Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
  • Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
  • Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and
  • Talicia®(omeprazole magnesium, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection.

    • The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.

    For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website www.cumberlandpharma.com.

    Forward-Looking StatementsThis press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

    SOURCE Cumberland Pharmaceuticals Inc.

    Source: HealthDay

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    Posted : 2026-04-20 15:00

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