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Morphine sulfate solution receives FDA approval
Manufacturer ensures product availability
The U.S. Food and Drug Administration (FDA) approved morphine sulfate oral solution for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients. This medicine will be available in 100 mg per 5 mL or 20 mg per 1 mL.
Oral morphine is commonly used in hospice care for patients who are unable to swallow tablets. In early 2009, the FDA issued a ban on the use of many pain control drugs that were being used for nonapproved purposes. Oral morphine initially was banned from use as a pain control medication for hospice patients and then excluded it from the ban in March 2009. At that time the FDA allowed continued use of the oral solution until at least one manufacturer filed the necessary documentation to request FDA approval for use of the drug to relieve moderate to severe, acute, and chronic pain.
This morphine sulfate oral solution is the only FDA-approved one available at this concentration. As part of the unapproved drugs initiative, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories (Columbus, OH) to ensure that there is enough drug available for patients.