NDMA Cautions Against Vaginal Antifungal Labels Implying 7-Day Superiority
This article was originally published in The Tan Sheet
Executive Summary
OTC vaginal antifungal labeling indicating seven-day treatments are more effective than the one- or three-day regimens should be avoided, Nonprescription Drug Manufacturers Association Senior VP and Director of Science & Technology William Soller, PhD, told FDA's Nonprescription Drugs Advisory Committee at a Sept. 11 meeting.
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FDA OTC Label Comprehension/Compliance Study Urged By NDAC Members
FDA should conduct "some general studies that aren't specific to products or symptoms that help us deter-mine a consumer's general ability to self diagnose" based on what they read in the label, Nonprescription Drugs Advisory Committee Consumer Representative Kathleen Hamilton suggested July 20. Her remarks came during the committee's review, with the Arthritis Advisory Committee, of Merck's Rx-to-OTC switch proposal for the muscle relaxant, Flexeril (cyclobenzaprine 5 mg) (1see related stories, pp. 3-8).
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FDA should conduct "some general studies that aren't specific to products or symptoms that help us deter-mine a consumer's general ability to self diagnose" based on what they read in the label, Nonprescription Drugs Advisory Committee Consumer Representative Kathleen Hamilton suggested July 20. Her remarks came during the committee's review, with the Arthritis Advisory Committee, of Merck's Rx-to-OTC switch proposal for the muscle relaxant, Flexeril (cyclobenzaprine 5 mg) (1see related stories, pp. 3-8).