The NDA code described as new indication for a currently marketed drug or switch from Rx to OTC is best described as

• A. New molecular entity
• B. New indication for a currently marketed drug or switch from Rx to OTC
• C. New combo or two or more drugs
• D. Already marketed drug without previously approved NDA

Answer: (B)

Supplemental New Drug Application is used to add a new indication to an already approved product or to switch a prescription drug to OTC. When a drug is already on the market, expanding its labeling to include a new indication or changing its status from Rx to OTC involves updating the existing NDA with new data and labeling via a supplemental NDA. This differs from a New Molecular Entity, which would be a completely new drug, or from scenarios like creating a new drug combination, which would involve a separate product filing.