Bryan Scleresol CFC exemption granted; FDA will accept ANDAs for three withdrawn Upjohn products.
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."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth