Press Release: European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte

The European Medicines Agency (EMA), on 24 August 2012, agreed a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. These measures are intended to protect patients from potentially harmful effects, while they also allow continued access to treatment for patients who have no suitable alternatives.

A recent inspection carried out jointly by France and the United Kingdom at the manufacturing site for DepoCyte in San Diego in the United States, Pacira Pharmaceuticals Inc., identified a number of manufacturing deficiencies. The findings relate to a lack of adequate sterility assurance in the manufacturing process. Following assessment of the available data, the CHMP concluded that these findings pose a theoretical risk of sterility failure, even though currently there are no data to indicate that there has been a negative impact on the finished product.

• Primary Source

EMA: Press Release: EMA/CHMP/555991/2012 (24.8.12) http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/08/WC500131277.pdf

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