Sangstat-UK has withdrawn its generic ciclosporin oral solution, Sangcya, from the market.
The withdrawal, effective from July 14, follows the release of data that shows a reduction in Sangcya's bioavailability relative to Novartis's Neoral oral solution when the drug is administered with apple juice.
Dr Ross Maclean (European regulatory affairs senior director, Sangstat) told The Journal on July 17 that the decrease in bioavailability was seen only in healthy volunteers and had not been seen in patients using apple juice to dilute Sangcya. The withdrawal was a precautionary measure pending a full review of the data. Dr Maclean added that as some patients might be adversely affected by abruptly changing to another ciclosporin product, it was important that "existing patients can and should continue to use Sangcya". Sangcya oral solution would therefore continue to be available on a named patient basis for those patients already taking the product.
Sangstat is applying to the Medicines Control Agency to make changes to Sangcya's summary of product characteristics. Although the changes had not been finalised, Dr Maclean said that a warning was likely to be added stating that patients should not switch between diluents.
Sangstat is offering to collect Sangcya from pharmacies and to reimburse the cost.