Unapproved Prescription Cough, Cold, and Allergy Drug Products

Many health-care providers may be unaware that unapproved drugs exist because the product labels of these drugs do not disclose that they lack FDA approval. The FDA recently took action against unapproved prescription oral cough, cold, and allergy drug products because of concerns about the potential risks of these products, particularly some extended-release formulations that have not been reviewed for quality. There is a potential for medication errors because product names and labeling have not been reviewed for potential confusion, with some products inappropriately labeled for use in children aged < 2 years. FDA-approved prescription drugs or drugs appropriately marketed as over the counter remain available for treatment of cough, cold, and allergy symptoms. Such products are of known efficacy, safety, identity, quality, and purity. Removing unapproved drugs from the marketplace and encouraging manufacturers of unapproved products to seek FDA review and approval is a top priority for the FDA. Since the initiation of the Unapproved Drugs Initiative in 2006, the FDA has removed ~ 1,500 unapproved products from the market and has worked with firms to bring other unapproved drugs into the approval process. The FDA remains committed to its mission of ensuring that safe and effective drugs are available to American consumers.    CHEST 2011; 140(2):295-300

Abbreviations: ACCP = American College of Chest Physicians; ANDA = abbreviated new drug application; DESI = Drug Efficacy Study Implementation; FDA = US Food and Drug Administration; FD&C = Federal Food, Drug, and Cosmetic; GRAS/E = generally recognized as safe and effective; IRS = identical, related, or similar; NAS/NRC = National Academy of Sciences/National Research Council; NDA = new drug application; NDC = National Drug Code; OTC = over the counter

The new drug approval and over-the-counter (OTC) drug monograph processes play an essential role in ensuring that all drugs are both safe and effective for their intended uses. Drugs that have approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), or active ingredients and labeling that are in accordance with an OTC drug monograph may be marketed legally in the United States (Table 1).

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