The European Medicines Agency (EMEA) has announced that it is lifting its recent ban on the sale of Viracept (nelfinavir) in Europe, according to the Associated Press. Sales of the protease inhibitor, which is sold in Europe by Roche, had been banned in August after a manufacturing impurity was founded in batches sold there.
The EMEA originally suspended Roche’s license to sell Viracept in Europe after the company reported that it had found higher than usual concentrations of ethyl mesilate, which can damage DNA and may cause cancer, in several batches of the drug. Roche responded by upgrading safety at the factory where the tainted samples of the drug were made, and promised to test future batches of Viracept to ensure that levels of ethyl mesilate are kept at a safe level.
After visiting Roche’s factory, EMEA officials announced that they were satisfied by the safety upgrades and reinstated Roche’s license, with sales of Viracept anticipated to resume in early 2008. A warning regarding the use of Viracept in the United States, where it is manufactured by Pfizer, remains in effect for HIV-positive children and pregnant women.
