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Home Industry News SkyePharma receives FDA approval for new Sular formulation

SkyePharma receives FDA approval for new Sular formulation

4th January 2008

SkyePharma and Sciele Pharma have announced that their new Sular formulation has been approved by the US Food and Drug Administration (FDA).

The regulatory body approved all four dosage strengths of the calcium blocking agent indicated for use in the treatment of high blood pressure.

It has also been revealed by the pharmaceutical companies that the new formulation uses SkyePharma’s Geomatrix technology which provides a lower dose of Sular for each of its current doses.

Dr Ken Cunningham, chief operating office of the SkyePharma, welcomed the decision and highlighted the important role of its patented Geomatrix process.

“This new Sular formulation is a further example of the versatility of the Geomatrix and will provide an additional revenue stream for SkyePharma,” he added.

The new formulation is expected to be launched during the first quarter of 2008 and SkyePharma has confirmed it will receive $2 million (one million pounds) upon the approval.

It will also receive low-to-mid single digit royalties on net sales of Sular and will be producing the formulation at its Lyon manufacturing facility.

Last month, SkyePharma confirmed that patient enrolment had been completed for the company’s current clinical trials for the development of Flutiform in the treatment of asthma

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