US Marketing OK For GW's Ultiva

Glaxo Wellcome has received a second approval to market its new analgesic Ultiva (remifentanil hydrochloride) for injection, this time from the US Food and Drug Administration. The first approval came earlier this year from Germany (Marketletter May 27), where the product has since been introduced.

Ultiva has been cleared in the USA for intravenous administration as an analgesic agent for use during the induction and maintenance of general anesthesia for in-patient and out-patient procedures, and for continuation as an analgesic into the immediate post-operative anesthesia care unit or intensive care setting. It was also approved for use as a component of monitored-anesthesia care, an anesthetic technique in which the patient is conscious and not intubated.