On January 13, 2011, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per dosage unit.1
The FDA has stated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing. Please visit the FDA website for more information on acetaminophen dosing: http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm
The FDA requested this change be effected by January 2014. Abbott is complying with this directive ahead of the FDA’s requested date and will introduce the following new formulations of Vicodin in the third quarter of 2012:
•VICODIN® (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg
•VICODIN ES® (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg
•VICODIN HP® (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg
In order to facilitate this transition, in the second quarter of 2012, Abbott is discontinuing the manufacturing and distribution of the current formulations of Vicodin.
Abbott will be working with pharmacies and distributors to help ensure the availability of the new Vicodin formulations, as well as process returns of the current Vicodin formulations. ...more
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