A new drug with no prior US market approval must obtain which application to enter the United States?

• A. Abbreviated NDA (ANDA)
• B. New Drug Application (NDA)
• C. OTC Monograph
• D. DESI Evaluation

Answer: (B)

For a brand-new drug with no prior FDA approval, the path to enter the US market is the New Drug Application. This process gathers all the data from laboratory studies and human trials showing safety and efficacy, along with manufacturing details and proposed labeling, and asks the FDA to authorize marketing. The Abbreviated NDA is reserved for generic versions of drugs that are already approved, not for a completely new substance. An OTC Monograph applies to nonprescription drugs that fit established categories, which isn’t the route for a newly developed prescription drug. DESI evaluations are historical reviews for drugs that were on the market before the 1962 law and are not the mechanism for bringing a new drug to market.