Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products

Zusammenfassung

The Food and Drug Administration (FDA) is amending the final monograph for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion caused by acute or chronic rhinitis) to add the ingredient levmetamfetamine (formerly l- desoxyephedrine) and to classify this ingredient as generally recognized as safe and effective for OTC use. The agency is also removing l-desoxyephedrine from the list of nonmonograph active ingredients. This final rule is part of the ongoing review of OTC drug products conducted by FDA.