In Brief: Ephedrine proposal
This article was originally published in The Tan Sheet
Executive Summary
Ephedrine proposal: Whitehall-Robins, Warner-Lambert and Sandoz ask FDA for an extension of the 30-day comment period to Oct. 27 on the agency's proposal to remove ephedrine from OTC status. Sandoz argued that 30 days is inadequate to consider the "substantial legal and policy issues" raised by the proposal. Warner-Lambert expressed concern that FDA's approach to ephedrine may be inappropriately applied to pseudoephedrine. NDMA also recently asked for an extension of the comment period ("The Tan Sheet" Aug. 14, p. 4)...
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Ephedrine proposal: Whitehall-Robins, Warner-Lambert and Sandoz ask FDA for an extension of the 30-day comment period to Oct. 27 on the agency's proposal to remove ephedrine from OTC status. Sandoz argued that 30 days is inadequate to consider the "substantial legal and policy issues" raised by the proposal. Warner-Lambert expressed concern that FDA's approach to ephedrine may be inappropriately applied to pseudoephedrine. NDMA also recently asked for an extension of the comment period ("The Tan Sheet" Aug. 14, p. 4).... |