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A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months

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Trial Profile

A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 29 Jun 2023

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At a glance

  • Drugs Ibuprofen (Primary)
  • Indications Fever; Pain; Postoperative pain
  • Focus Pharmacokinetics
  • Sponsors Cumberland Pharmaceuticals

    • Most Recent Events

    • 26 Jun 2023 According to a Cumberland Pharmaceuticals media release, the positive results from this study supported recent U.S. FDA approval of expanded labeling of Caldolor in infants 3 to 6 months of age.
    • 09 Jun 2023 Results evaluating the pharmacokinetics and safety in children 1-6 months of age, published in the Pediatric Drugs.
    • 17 Mar 2020 According to a Cumberland Pharmaceuticals media release, Next steps include finalizing the full study report for submission to the FDA and then determining whether an additional pediatric indication will be available

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