Novartis, SkyePharma receive FDA approval for asthma spray Foradil

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novartis BASEL (AFX) - Novartis (nyse: NVS) AG and joint venture partner SkyePharma PLC (nasdaq: SKYE) have received market approval for their asthma spray Foradil Certihaler from the US Food and Drug Administration (FDA), following modifications to the product.

The product was recalled in Germany and Switzerland early this year on concern the inhaler was delivering variable doses of the drug.

SkyePharma has since been modifying the device and resubmitted it with the US regulator.

The UK company will earn a royalty on sales of the product, and is waiting to find out the Swiss pharma giant's plans for its commercial launch.

The Foradil Certihaler has been approved in 27 countries outside the US, and SkyePharma is in discussion with Novartis with respect to commercial launch in these territories.

'We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products,' SkyePharma chief executive Frank Condella said.

source AFX