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news.Global generic pharmaceutical company Alpharma has been notified by FDA that its pending application for the 200mg dose of its chronic pain capsule Kadian has been given approvable status.
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Kadian is Alpharma’s branded sustained release morphine sulfate product and is currently marketed in 20mg, 30mg, 50mg, 60mg and 100mg dosages. The company plans to launch the new dosage form following final FDA approval.
“We are extremely pleased to receive approvable status on this important new higher dosage of Kadian,” commented Dr Ronald Warner, president of Alpharma’s branded products business. “This added dosage form, which will be marketed by our recently expanded sales force, will help physicians individualize their patients treatments by offering more choices in managing their pain.”
Following this announcement and the release of its Q1 2005 results, the company’s shares have risen by more than 10%. Alpharma’s first quarter net revenues were $378.1 million, an increase of 21% versus 2004, boosted by the fourth quarter 2004 launches of gabapentin capsules and tablets.