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Minoxidil topical cream petition

This article was originally published in The Tan Sheet

Executive Summary

Law firm Baker & Hostetler asks FDA to allow an abbreviated new drug application to change the topical dosage form for private-label Rogaine, according to a petition filed Dec. 11. The petition notes that changing the dosage for the hair regrowth product from a topical solution to a cream provides better application control and reduces the risk of skin irritation to non-affected areas. It requests the dosage change for the generic versions of Rogaine (For Women) 2 percent and Rogaine Extra Strength (For Men) 5 percent. The foam delivery form of Rogaine is patented through 2019 (1"The Tan Sheet" Sept. 11, 2006, p. 5)

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