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In Brief: Legatrin PM

This article was originally published in The Tan Sheet

Executive Summary

Legatrin PM: Columbia Labs soon plans to launch reformulated version of its Legatrin nocturnal leg cramp product. Legatrin PM does not contain quinine but does contain a combination of acetaminophen and diphenhydramine. The product will be promoted for occasional sleeplessness and muscle aches and pains such as those associated with leg cramps, the firm said. FDA banned the use of quinine in leg cramp products in an Aug. 22, 1994 final rule on the product class, effective Feb. 22 ("The Tan Sheet" Aug. 22, 1994, p. 8). Separately, FDA recently sent letters to 44 companies warning that prescription quinine can no longer be sold for leg cramps without an approved NDA or ANDA. The letters follow a Sept. 8, 1994 citizen petition from Public Citizen's Health Research Group requesting such action...

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