CHMP recommends Viracept reinstatement
Swiss drugmaker Roche says that the European Medicines Agency's (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that marketing authorization for the HIV drug Viracept (nelfinavir) is re-instated. The committee said that it is satisfied that measures taken by the firm have rectified the contamination problems that led to the product's suspension earlier this year (Marketletter August 13).
The revocation of marketing approval, which did not affect sales of Viracept in the USA where it is marketed by Pfizer, followed the discovery of the genotoxic compound, ethyl mesilate, in several batches of the drug's active component.
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