Overindulgence TFM Gets Bloated With Belching, Gas Indications
This article was originally published in The Tan Sheet
Executive Summary
FDA will allow for the inclusion of two new indications for bismuth subsalicylate products, according to a proposed amendment to the overindulgence Tentative Final Monograph in the Jan. 5 Federal Register
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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)...
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)...
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)...