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Astra USA Naropin safety data includes 218 C-section, 220 labor and delivery patients.

Executive Summary

ASTRA USA NAROPIN DATA INCLUDE EIGHT C-SECTION, NINE L&D SAFETY STUDIES, which were presented at a Dec. 12 Anesthetic & Life Support Drugs Advisory Committee review of the neuromuscular blocker ropivacaine. Astra USA presented data from eight studies performed in 218 Cesarean section patients receiving doses up to 150 mg of ropivicaine .5% concentration and nine studies of 220 labor and delivery patients receiving .25% ropivacaine. "The Pink Sheet" (Dec. 18, 1995, p. 7) incorrectly reported that Naropin safety data for use in pregnant women were derived exclusively from animal studies.



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