Sciele Pharma, Inc. Announces Acceptance by FDA of sNDA for New Sular Formulation
Published: Sep 04, 2007
ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Sciele's new Sular formulation, with a Pharmacy Drug User Fee Act (PDUFA) date of November 2, 2007. The new Sular formulation utilizes SkyePharma's (LSE:SKP) patented Geomatrix™ technology, which is designed to provide a lower dose of Sular for each of its current doses.