LONDON, UK, 5 February 2008-- SkyePharma PLC (LSE:SKP.L - News) has been informed that
the United States Food and Drug Administration (FDA) has extended the
Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's Requip(R) XLTM Extended Release tablets.
The PDUFA action date is the date
by which the FDA is expected to issue a response on a pending new drug
application. Following the approvable letter for Requip XL issued in December
2007, GlaxoSmithKline submitted a response to the FDA. A final decision from
the FDA had been expected in Q1 2008. However, GSK has recently submitted
additional information on food effect to the FDA. The Agency has determined that
they would not have sufficient time to review this information prior to the Q1
action date and the final decision is now expected to be received in Q2 2008.
Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist
indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It
uses SkyePharma's patented GEOMATRIXTM technology and has been designed to
provide a steady rate of absorption in the body to help reduce daily blood
plasma fluctuations. The product is expected to be available in pharmacies
shortly after the anticipated approval.
SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LP
Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known
For further information please contact:
Frank Condella +44 20 7491 1777
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 twelve 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 http://www.skyepharma.com
Ropinirole Extended-Release Tablets have been approved in 13 European countries
and are marketed by GlaxoSmithKline under the brand names Requip XL, Requip
Modutab, Requip LP and Requip Depot. GlaxoSmithKline is one of the world's
leading research-based pharmaceutical and healthcare companies. More information
on GlaxoSmithKline is available at the company's website at http://www.gsk.com.