The FDA announced it intends to remove certain unapproved prescription cough, cold, and allergy drug products that have not been evaluated by the FDA for safety, effectiveness, and quality. These drug products are marketed without approved applications, and may be inappropriately labeled for use in infants and young children.
Companies that have previously listed products subject to today’s action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. Companies that have not previously listed products subject to today’s action with FDA are expected to stop manufacturing and shipping their products immediately. Before marketing, the companies must obtain FDA approval of a New Drug Application (NDA) or an abbreviated NDA (ANDA) or comply with an FDA OTC drug final monograph.
A listing of the unapproved products can be accessed at: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm. Patients who have any of the affected products in their possession should contact their healthcare professional to discuss alternatives.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245279.htm.