EU suspends marketing authorization for GE Optison
The EMEA's committee for medicinal products said marketing authorization holder, GE Healthcare, was unable to provide an authorized importer for Optison to ensure the supply of the medicinal product in the European market and prove good manufacturing practice (GMP) compliance at the manufacturing site in the United States.
The regulators recommended that the marketing authorization for Optison be suspended.
The EMEA noted that Optison currently is not marketed in the European Union.
GE said it had been informed that the suspension would occur until the GMP matters had been resolved. Global sales of Optison were halted in November 2005 when the GMP matters were identified and since that time, GE and the manufacturing plant have been working to resolve the issues. In November 2007, the FDA approved the plant to resume production for sales in the U.S., according to GE.
“In the next phase of the planned return to full authorization, the plant was inspected by the Norwegian Medicines Authority,” according to a written statement from a GE spokesperson. “We are waiting for the result of the inspection and, when successful, we expect that the marketing authorization suspension in Europe will be lifted.”
GE said it intends to resume sales in Europe as soon as the product manufacture is re-approved for European sales.