Viracept was recalled in June and has now had its license put on hold. The European Medicines Agency (EMEA), which handles drug safety, recommended the Commission suspend Roche’s marketing authorisation for the drug. This is the first time the regulator has called for such a wide-spread recall.
Viracept was found to contain higher than normal levels of ethyl mesilate which can harm DNA and cause cancer.
The drug can only go back on the market after a safety assessment of new data submitted to the EMEA.
A Roche spokesperson told Reuters that the company was aiming to start manufacturing the drug again by September or October. Roche was granted marketing approval for Viracept back in 1998.