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Regulatory Actions

Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation

Published in Medical Letter on the CDC and FDA, July 22nd, 2007

Sciele Pharma, Inc. (NASDAQ: SCRX) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental new drug application (sNDA) for its new Sular formulation. The new Sular formulation utilizes SkyePharma's (LSE:SKP) patented Geomatrix(TM) technology, which is designed to provide a lower dose of Sular for each of its current doses.

Keywords: Drugs, FDA, Nisoldipine, Pharmaceuticals, Regulatory Actions, Sular, Therapy, Treatment, U.S. Food and Drug Administration, Sciele Pharma.

This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports. Copyright 2007, Medical Letter on the...

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