| CATEGORY: SMALL CAPS NEWS SECTOR: PHARMACEUTICALS & BIOTECHNOLOGY |
SkyePharma buoyed by drug's FDA progress |
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Mon 10 Dec 2007
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LONDON (SHARECAST) - Biotech group SkyePharma is on the up after announcing that a product which uses the group’s Geomatrix technology is on the final leg towards approval from the US Food and Drug Administration (FDA).
The FDA has issued an approvable letter for GlaxoSmithKline’s Requip XL Extended Release tablets, which use SkyePharma’s patented Geomatrix technology. An approval letter sets out certain conditions which must be met before the FDA will give final approval for a drug’s release in the US market.
Requip XL is a once a day oral medicine developed for the treatment of the signs and symptoms of Parkinson’s disease. It has been approved in eight European countries and there is a mutual recognition procedure in place in 17 additional European countries. The tablets are expected to be released in these European countries starting some time in the first quarter of 2008.
SkyePharma's Geomatrix technology is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations.
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