Alpharma Receives FDA Approval for Kadian 80mg Capsules
FORT LEE, N.J., October 30, 2006 -- Alpharma Inc. , a global specialty pharmaceutical company, today announced that it has been notified by United States Food and Drug Administration("FDA") that its pending application for Kadian 80mg capsule has received approval. The company expects to launch this new dosage strength in the fourth quarter of 2006. Kadian is Alpharma’s branded sustained release morphine sulfate product and is currently marketed in 20mg, 30mg, 50mg, 60mg and 100mg dosages. The added dosage strength is intended to assist in physicians efforts to individualize their patient’s treatments by offering more choices in managing their pain.
The company has conducted in vivo studies to evaluate the interaction of alcohol consumption with Kadian. The results indicate that the concomitant use of tested levels of alcohol with Kadian has no significant impact on mean morphine blood levels. The company has provided this data to the FDA and any future labeling implications will be determined following the completion of this review. Kadian product labeling, pending completion of this FDA review, will include the Schedule II extended release opioid box warning, excluding any precautionary language related to alcohol.
Source: Alpharma Inc.
Posted: October 2006