OTC Bronchodilators With Ephedrine Permitted In New Proposed Rule
This article was originally published in The Tan Sheet
Executive Summary
Additional warnings and other revised labeling would be required for bronchodilator products containing ephedrine or epinephrine under an FDA proposed rule published in the July 13 Federal Register
You may also be interested in...
FDA’s Agenda Slates September For Cough/Cold Proposal, Sunscreen Rule
Meeting deadlines on regulatory agenda actions, such as finalizing OTC monographs, could be a higher priority for FDA under its new management
Unified agenda
FDA will announce a Notice of Proposed Rulemaking in June on "the use of stimulant active ingredients to relieve symptoms associated with a hangover" in OTC products, the agency announces in HHS' semi-annual "unified agenda." The document, which was published in the Federal Register April 24, also notes that final action is slated for December on a proposal to require additional warnings for OTC bronchodilators containing ephedrine or epinephrine. The proposed amendment was issued by FDA in July (1"The Tan Sheet" July 18, 2005, p. 10). FDA also expects to take final action in August on a proposed rule to allow new indications for bismuth subsalicylate products. The proposal was announced in January 2005 (2"The Tan Sheet" Jan. 10, 2005, p. 7)...
Primatene Mist Availability Not “Essential,” Advisory Panel Says
Questions about the appropriateness of asthma for OTC treatment led to an FDA advisory panel vote in favor of removing Wyeth's Primatene Mistfrom the market during a Jan. 24 meeting in Bethesda, Md