FDA News

FDA Approves Alpharma's KADIAN New 200 Mg Strength

(March 22, 2007)--Alpharma , a global specialty pharmaceutical company, announced that it has been notified by United States Food and Drug Administration("FDA") that its pending application for KADIAN 200mg capsule has received approval. The company expects to launch this new dosage strength in the second quarter of 2007. KADIAN(R) is Alpharma's branded extended release morphine sulfate product and is currently marketed in 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg 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.

In 2006, the company conducted in vivo studies to evaluate the interaction of alcohol consumption with KADIAN. The results indicated that the concomitant use of tested levels of alcohol with KADIAN had no significant impact on mean morphine blood levels. The FDA has completed a review of this data and has concluded that the KADIAN black box warning does not need to include any precautionary language related to alcohol. The company believes that the exclusion of this precautionary language will help further differentiate KADIAN in the marketplace.

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