FDA Approval for Alpharma's Kadian 80mg

Alpharma says that it has been notified by the US Food and Drug Administration that its pending application for Kadian (branded sustained-release morphine sulfate) 80mg capsule has received approval. The company expects to launch this new dosage strength in the fourth quarter of 2006. The product 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, according to the firm.

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 the drug has no significant impact on mean morphine blood levels. Alpharma says it has provided this data to the FDA and any future labeling implications will be determined following the completion of this review. Kadian labeling, pending completion of this review, will include the Schedule II extended-release opioid box warning, excluding any precautionary language related to alcohol.