United States of America (USA/135: Human Drug Products)
The Food and Drug Administration (FDA) is proposing to amend the tentative final monograph (TFM) for over-the-counter (OTC) cough-cold combination drug products to remove the combination of an oral bronchodilator (products containing ephedrine or its salts) and an expectorant, and to reclassify this combination drug product as Category II (not generally recognized as safe and effective for OTC use). FDA is also proposing to classify the combination of an oral bronchodilator and an oral nasal decongestant as Category II. FDA is issuing this notice of proposed rulemaking after considering data and information on the appropriateness of these combination drug products to treat mild asthma. Elsewhere in this issue of the Federal Register, FDA is proposing to amend the final monograph (FM) for OTC bronchodilator drug products to require additional labeling for all ingredients included in the FM. These proposed rules are part of FDA's ongoing review of OTC drug products.
Final Comment Date: November, 10, 2005
(Texts provided by the World Trade Organization.)