For several years, the FDA has been actively involved regarding drug safety for both legend and over the counter drugs. Now, the FDA is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage. Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until January 14, 2014 to request that FDA withdraw approval of the product’s application, after which they may be subject to action by FDA.
Be advised that the FDA originally posted notice on 1-10-2011 , giving industry 3 years to implement these changes. To view the notice, go to http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0021-0001.
A list of the affected products can be located on the attached Excel spreadsheet.
October 30, 2013