FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
Approval is part of Agency's unapproved drugs initiative
SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ -- The U.S.
Food and Drug Administration today 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 milligrams per 5 mL or 20 milligrams per 1 mL.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)
This is the only FDA-approved morphine sulfate oral solution
available at this concentration. Although the use of this medicine
to manage pain has been common practice for many years, this form
and concentration of morphine was not FDA-approved until now.
Today's action is part of the FDA's unapproved drugs initiative.
As part of this program, the FDA has worked with the manufacturer
of the now-approved product, Roxane Laboratories, to ensure that
there is enough drug available for patients. The FDA will also be
working with patient organizations and prescribers so that they are
aware that an approved product is available, and can notify the FDA
if there are any problems with availability.
"An important goal of the unapproved drugs initiative is to make
sure that marketed drugs meet current FDA standards," said Douglas
Throckmorton, M.D., deputy director for the FDA's Center for Drug
Evaluation and Research. "Our action today reflects a careful
balance between ensuring patient access to necessary medicines,
while making sure companies comply with the law."
One benefit of the FDA approval process is a requirement for
manufacturers to provide sufficient information on how to safely
prescribe and use a drug. Manufacturers may also have to establish
additional safety measures to manage unique risks of a medicine.
For this formulation of morphine, the manufacturer had to develop a
safety program prior to approval to address the known risks of
morphine misuse, abuse and overdose.
For more information March 31, 2009 Warning Letters, companies, and affected products
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Enforceme
ntActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm
List of FDA-approved drug products http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm Media Inquiries: Christopher Kelly, 301-796-4676; christopher.kelly@fda.hhs.gov mailto:Consumer Inquiries: 888-INFO-FDA
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PRN Photo Desk, photodesk@prnewswire.com
Source: U.S. Food and Drug Administration
CONTACT: Christopher Kelly of FDA, +1-301-796-4676;
christopher.kelly@fda.hhs.gov
Web Site: http://www.fda.gov/
Posted: January 2010
