Executive Summary

Chiron/Ciba-Geigy vaccine joint venture's Italian subsidiary Sclavo, SpA, has had its establishment license revoked, FDA says in Dec. 20 Federal Register. Biocine acquired Sclavo in 1991 and in October 1992 withdrew all of its products from the U.S., citing unapproved manufacturing changes ("The Pink Sheet" Nov. 9, 1992, T&G-9). The Federal Register notice states that, following inspections of Sclavo by FDA in September and December 1992, FDA notified Sclavo of its intent to revoke the ELA. In a June response, Biocine requested that the ELA be withdrawn. FDA revoked the ELA effective July 27. Sclavo's U.S. business was small, with sales of less than $1 mil. compared to Italian sales of about $ 50 mil. The company was licensed to produce diphtheria, tetanus and pertussis toxoids in various combinations, tuberculin and cholera vaccine