MedImmune’s Respivir

Executive Summary

Will be reviewed by FDA's Blood Products Advisory Committee on first day of Sept. 23-24 meeting. Respivir (respiratory syncytial virus immune globulin intravenous) will be reviewed as a treatment to reduce the incidence of severe RSV in infants with premature gestation and in children with chronic pulmonary disease. The PLA for Respivir (93-0142) was submitted by the Massachusetts Public Health Biologic Labs under a licensing agreement with Gaithersburg, Md.-based MedImmune ("The Pink Sheet" Jan. 11, T&G- 8). Respivir will be copromoted by Lederle under a deal announced in July ("The Pink Sheet" July 19, T&G-11). The meeting will be held at the Holiday Inn Bethesda, Md. beginning at 8:30 a.m. both days.