Item 8.01 Other Events
On May 15, 2023, Cumberland Pharmaceuticals Inc. ("Cumberland" or 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 infants. The non-narcotic agent may now be administered for
the treatment of pain and fever in patients three months to six months of age.
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
these young children.
Caldolor is now approved by the U.S. Food and Drug Administration (FDA) for use
in adults and pediatric patients three months and older, for the management of
mild to moderate pain as a sole therapy, and for the management of moderate to
severe pain as an adjunct to an opioid. A series of published clinical studies
have demonstrated that Caldolor significantly reduces patient pain, while also
significantly reducing patients' need for opioids.
Full prescribing and safety information can be found at the brand's website
www.caldolor.com.
A copy of the release is furnished as Exhibit 99.1 .
Exhibit No. Description
99.1 Press release dated May 15, 2023
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