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Executive Summary

STUART's DIPRIVAN APPROVED FOR ADULT INTENSIVE CARE UNIT USE on March 8 for the sedation of intubated, mechanically ventilated or respirator-controlled patients. Diprivan (propofol), which has been marketed since 1989 as an anesthetic for inpatient and outpatient use, is the first agent to be labeled for sedation in critically ill patients in the U.S. The supplemental NDA was submitted in September 1991. Approval of the new indication for the general anesthetic came three-and-one-half months after a review by FDA's Anesthetic and Life Support Drugs Advisory Committee in open and closed sessions ("The Pink Sheet" Nov. 30, 1992, p. 9). The committee did not vote on the new indication in open session. "Diprivan provides medical professionals the ability to rapidly increase or decrease depth of sedation...within minutes," Stuart said in a March 10 press release. "Depending on their needs, patients can be placed in a deeper state of sedation to avoid stress and/or discomfort or can be wakened to allow [central nervous system] evaluation of interaction with medical professionals or family members." In clinical trials, Diprivan was compared to opioids and benzodiazepines in 550 ICU patients, of whom 302 received Diprivan. The anesthetic was found to be similar in efficacy to the other agents in maintenance of sedation. A higher incidence of hypotension in Diprivan-treated patients than in patients receiving comparator agents caused the company to reduce its initial dosing recommendation for Diprivan from 10 mcg/kg per minute to 5 mcg/kg per minute. Stuart filed data in May 1992 for use of Diprivan as a general anesthetic in the pediatric population. FDA has encouraged the company to submit an IND for study of the drug in the pediatric ICU setting despite reports that Diprivan may be associated with cardiac events in children being treated in the ICU. FDA's Anesthetic and Life Support Advisory Committee concluded in September that the link between Diprivan and pediatric deaths in the ICU could not be established from the existing data ("The Pink Sheet" Sept. 7, 1992, p. 14). Stuart said it continues to evaluate the need for clinical studies in this area.

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