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Executive Summary

CIBA's PRISCOLINE (TOLAZOLINE) IS DESI-EFFECTIVE IN NEONATES with persistent pulmonary hypertension, but lacks "substantial evidence of effectiveness" for other labeled indications, FDA said in an Aug. 28 Federal Register notice. Under the DESI review program, FDA classified Priscoline in 1979 as lacking substantial evidence of effectiveness in treating spastic peripheral vascular disorders associated with a number of diseases. While that status has not changed, FDA noted that the agency and Ciba-Geigy "became aware that there was a potential critical medical need for Priscoline Inj. in treating neonates with pulmonary vasocontriction and hypertension." Since 1979, Ciba has supplemented its NDA with published studies in support of this use, FDA said. Under the new approved labeling, Priscoline is now indicated "for the treatment of persistent pulmonary hypertension of the newborn ('persistent fetal circulation') when systemic arterial oxygenation cannot be satisfactorily maintained by usual supportive care (supplemental oxygen and/or mechanical ventilation)." The labeling adds that Priscoline "should be used in a highly supervised setting, where vital signs, oxygenation, acid base status, and fluid electrolytes can be monitored and maintained." The revised "dosage and administration" section reads: "An initial dose of 1 to 2 mg/kg via scalp vein, followed by infusion have usually resulted in significant increases in arterial oxygen." Ciba-Geigy has until the end of October to file a supplemental NDA and until the end of the year to revise the labeling, the notice indicates.

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