5th Nov 2007 14:00
Skyepharma PLC05 November 2007 SkyePharma PLC FDA Extends PDUFA Date on New Sular Formulation to 2 January 2008 LONDON, UK - 5 November 2007 -- SkyePharma PLC (LSE: SKP) today announces thatSciele Pharma Inc.'s (NASDAQ:SCRX) new Sular formulation, which was filed as asupplemental New Drug Application (sNDA) on 30 June 2007 with the U.S. Food &Drug Administration (FDA), has had its Pharmacy Drug User Fee Act (PDUFA) dateextended to 2 January 2008 (from 2 November 2007). Sular(R) is a calciumchannel blocking agent for the treatment of high blood pressure. The new Sularformulation utilizes SkyePharma's patented GeomatrixTM technology, which isdesigned to provide a lower dose of Sular for each of its current doses. For further information please contact: SkyePharma PLC Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer +44 207 491 1777Peter Grant, Finance Director Financial Dynamics (London enquiries)David Yates / Deborah Scott +44 207 831 3113 Trout Group (US enquiries)Christine Labaree / Seth Lewis +1 617 583 1308 About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has eleven approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe world by leading pharmaceutical companies. For more information, visitwww.skyepharma.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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