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MCA reclassification

This article was originally published in The Tan Sheet

Executive Summary

First two products to be considered under Medicines Control Agency's new drug reclassification system are J&J Consumer Pharmaceuticals' Nizoral Dandruff Shampoo 2% (ketoconazole) and Pharmacia's Regaine Regular Strength (minoxidil 2%). Firms have applied to switch legal status from "Pharmacy" to "General Sale List," MCA says. J&J's Nizoral switched from Rx to pharmacy status in 1996; indications will be for "prevention and treatment of dandruff only," UK agency says. Pharmacia's Regaine will have "improved information on the pack, label and leaflet," as well as dedicated hot line, Web site. New reclassification strategy went into effect April 1 (1"The Tan Sheet" May 6, 2002, p. 4)...

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