Audio Transcript

Now let's look at the pathways for which you can demonstrate the safety and effectiveness of your products and legally market them. The FDA's evidence-based system of drug approval and the Over-the-Counter (also known as OTC) monograph system play essential roles in ensuring that all drugs used by the American public are both safe and effective. It is the responsibility of the company to follow the appropriate approval pathway when seeking to market a drug to the American public. Once an application for marketing is sent to FDA, a multidisciplinary team of physicians, statisticians, chemists, pharmacologists, and other scientists within the Center for Drug Evaluation and Research (also known as CDER) will review the application and make a determination on whether to approve or not approve the drug.

The FDA is committed to facilitating voluntary compliance by firms that market and distribute unapproved drugs. The FDA-approved pathways a firm can take to legally market drugs are:

• The Abbreviated New Drug Application (ANDA),
• The New Drug Application (NDA),
• Or an Over-the-Counter (OTC) Monograph.

Approved NDAs or ANDAs are listed in FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations. We commonly refer to this resource book as the Orange Book. The Orange Book is actually not a book any longer. Rather, the Orange Book is a web-based list that can be accessed at the CDER website. This electronic Orange Book allows you to search a number of fields, including the active ingredient and the proprietary name or trade name of a drug product. Approved products will have an application number listed in the application number ('Appl No') field in your search results.

The electronic Orange Book is updated monthly with most new entries. New generic drug approvals (ANDAs), however, are updated daily.