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STUART's DIPRIVAN CARRIES APPROVED LABELING FOR "RAPID RECOVERY"

Executive Summary

STUART's DIPRIVAN CARRIES APPROVED LABELING FOR "RAPID RECOVERY" from anesthesia. Approved Oct. 2 for induction and maintenance of anesthesia, Diprivan (propofol) labeling states: "Recovery from anesthesia is rapid. Following induction (2.0 to 2.5 mg/kg Diprivan injection) and maintenance (0.1 to 0.2 mg/kg/min) of anesthesia for periods of up to two hours, the majority of patients are generally awake, responsive to verbal commands, and oriented within eight minutes." The reference to a specific time period during which patients recover represents a departure from FDA's original position on labeling for the drug. At the Aug. 28 advisory committee review of Diprivan, FDA said it opposed using the seven-to-eight minute recovery time proposed by Stuart because it represented an average, and did not take variability of patient response into account ("The Pink Sheet" Sept. 4, p. 3). The advisory committee concurred with FDA, and instead recommended the statement that patients recovered more quickly with Diprivan than with thiopental. Although labeling for Diprivan does not discuss comparative recovery time or quality recovery to other anesthetics, Stuart is emphasizing that advantage. In an Oct. 25 release announcing approval of the drug, the firm said that "Diprivan will result in a significantly more rapid and better quality recovery from anesthesia with a low incidence of troublesome side effects compared to standard anesthetic agents currently on the market." Diprivan was approved as a 1B drug (a new molecular entity representing a modest therapeutic advance) just five weeks after its advisory committee review. Diprivan will be launched Nov. 3. The price to wholesalers is $41.50 for five 20 ml ready-to-use ampules. A sedative-hypnotic agent, Diprivan is the first in a new class of anesthetics, called alkylphenols, and is not a controlled substance, Stuart noted. A number of anesthetics, such as thiopental (Abbott's Pentothal) are controlled substances. Stuart is also highlighting the cost savings potential from the rapid recovery of Diprivan. "Diprivan can serve as a cost-effective replacement for standard induction and volatile maintenance agents, providing an improved speed and quality of recovery with a low incidence of post-operative nausea, vomiting and headache," the firm said. Labeling for Diprivan notes in the "Indications" section a number of uses for which the anesthetic is not recommended. For example, labeling states that the drug "is not recommended for obstetrics, including cesarean section deliveries, because there are insufficient data to support its safety to the fetus."

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