CFC-free inhalers
Executive Summary
GlaxoSmithKline is urging FDA and the Office of Management & Budget to issue final rule on ozone-depleting substances. The proposed rule, issued in September 1999, laid out FDA's suggested approach to phasing out metered dose inhalers that contain chlorofluorocarbons (1"The Pink Sheet" Sept. 9, 1999, p. 3). GSK met June 3 with representatives from OMB, Center for Drug Evaluation & Research Associate Director-Policy Jane Axelrad and Office of Drug Evaluation II Director Robert Meyer, MD, to discuss expediting the rule. The company launched the CFC-free inhaler Ventolin HFA (albuterol) in February, and is phasing out its CFC-containing Ventolin product...