FDA clears new Sular formulations
UK-based drugmaker SkyePharma and US partner Sciele Pharma say that the Food and Drug Administration has approved new formulations of the calcium channel blocker Sular (nisoldipine) for the treatment of high blood pressure. Specifically, the FDA has cleared use of the product at all four dosages developed using SkyePharma's Geomatrix technology.
US approval for the new Sular formulations entitles the UK firm, which will manufacture the product at its facility in Lyon, France, to a $2.0 million milestone payment as well as low-to-mid single-digit royalties on net sales. SkyePharma's chief operating officer, Ken Cunningham, said that the news is a further indication of the versatility of its dose-sparing Geomatrix technology.
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