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...
You may also be interested in...
More than one CFC-free product alternative must be available before FDA phases out a CFC-containing metered dose inhaler that is available under multiple NDAs or in multiple strengths, the agency suggests in a proposed rule on ozone depleting substances (ODS) published in the Sept. 1 Federal Register.
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.