Bryan Scleresol CFC exemption granted; FDA will accept ANDAs for three withdrawn Upjohn products.

Executive Summary

BRYAN SCLERESOL CFC USE EXEMPTION GRANTED BY FDA, according to a May 21 Federal Register notice. Bryan's petition for classification of the aerosolized talc product as an "essential use" of chlorofluorocarbons was published by FDA March 1. "Based on the evidence before it in the petition and in Bryan's NDA for the drug product, the agency has determined that for many patients suffering from pleural effusions, the use of sterile talc provides a special benefit that would be unavailable without the use of CFCs."