Sandoz OTC clemastine claim for common cold cleared by FDA advisory cmte..
This article was originally published in The Tan Sheet
Executive Summary
SANDOZ' OTC CLEMASTINE FOR COMMON COLD: DATA SUPPORT APPROVAL of the new indication for the Rx-to-OTC switch antihistamine, FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees concluded Nov. 16. The joint committee unanimously agreed that OTC clemastine fumarate 1.34 mg should be approved for the treatment of rhinorrhea and sneezing associated with the common cold in adults and children over age 12. The committees based their recommendation on the results of two randomized, double-blind, placebo-controlled trials.
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