The European Medicines Agency (EMEA) has withdrawn the marketing authorization for GE Healthcare's Optison ultrasound contrast agent, a move that the Chalfont St. Giles, U.K., company said is a routine part of the firm's effort to renew regulatory approval for the product.
Optison originally received marketing authorization in Europe in 1998, although GE has not sold the product in Europe since pulling it off the market in November 2005 due to good manufacturing practices (GMP) issues at the product's manufacturing plant in the U.S. GE has been working on a renewal of Optison's license prior to reintroducing the agent in the European market.
In June 2008, the European Commission issued a decision to suspend the authorization after a recommendation issued by the EMEA in March. The EMEA said it took the step as part of a risk-benefit analysis of Optison during the "second renewal procedure" for the product's authorization, which must be renewed every five years under EU rules. The agency said that GE was not able to provide an authorized importer for Optison to ensure supply in the European market or to prove adherence to GMPs at Optison's manufacturing site in the U.S.
GE spokesperson Corey Miller said that GE had been expecting the suspension, and that the company is working to resolve the GMP issues. The U.S. Food and Drug Administration gave the U.S. facility the go-ahead to resume manufacturing in November 2007, and GE is awaiting the outcome of an inspection by the Norwegian Medicines Authority (NOMA).
"We are waiting for the result of the inspection and when successfully completed, we expect that the Marketing Authorization suspension in Europe will be lifted," Miller said. "GE Healthcare intends to resume sales in Europe as soon as the product manufacture is re-approved for European sales."
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