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Glaxo Wellcome Ultiva

Executive Summary

Efficacy supplement for analgesic remifentanil approved Oct. 15. Pediatric use section of labeling now states, "efficacy and safety of Ultiva as an analgesic agent for use in the maintenance of general anesthesia" has been established for pediatric surgery patients aged 1-12 years. "However, Ultiva has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored analgesic care." Glaxo plans to submit neonatal studies in the next few weeks, which if accepted, will provide a pediatric indication and six months added exclusivity

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