SKYEPHARMA AND SCIELE PHARMA ANNOUNCE ACCEPTANCE BY FDA OF SNDA
FOR NEW SULAR FORMULATION
PDUFA DATE OF 2 NOVEMBER 2007
LONDON, UK and ATLANTA, US, 5 September 2007 - SkyePharma PLC (LSE:SKP) and
Sciele Pharma. Inc. (NASDAQ: SCRX ) today announce 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 2 November 2007. Sular(R) is a calcium channel blocking agent for the
treatment of high blood pressure. The new Sular formulation utilizes
SkyePharma's patented Geomatrix(TM) technology, which is designed to provide a
lower dose of Sular for each of its current doses.
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group (US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new
formulations of known molecules to provide a clinical advantage and life-cycle
extension. The Company has eleven approved products in the areas of oral,
inhalation and topical delivery. The Group's products are marketed throughout
the world by leading pharmaceutical companies.
For more information, visit www.skyepharma.com
This information is provided by RNS
The company news service from the London Stock Exchange
SkyePharma PLC announces Regulatory Approval
| Source: SkyePharma PLC
London, UK--(Marketwire - September 5, 2007) -