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Home Industry News SkyePharma and Sciele announce SNDA application acceptance

SkyePharma and Sciele announce SNDA application acceptance

6th September 2007

SkyePharma and Sciele Pharma have announced that the US Food and Drug Administration (FDA) has accepted the two firms’ supplemental new drug application (SNDA) for a new Sular formulation.

The formation for the Sciele product Sular – which is indicated for the treatment of hypertension – has been accepted with a Pharmacy Drug User Fee Act (PDUFA) date of November 2nd 2007.

Sular’s new formulation utilises the SkyePharma Geomatrix technology, which the companies have said is designed to provide a “lower dose of Sular for each of its current doses”.

The treatment functions as a calcium channel blocking agent and through this treats high blood pressure.

Sciele Pharma was founded in 1992 and the Atlanta-based firm now employs some 900 people.

London Stock Exchange-listed SkyePharma is based in the UK and in June announced the appointment of Jean-Charles Tschudin, formerly of Johnson & Johnson and Schering-Plough, as a non-executive director.

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