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Key Points
Audio Transcript
Now let's review the OTC pathway to approval. OTC drugs can be legally marketed under an approved NDA, an approved ANDA, or pursuant to an OTC drug monograph. We've already discussed the ANDA and NDA pathways. This section will focus on the OTC Drug Review and monograph pathway.
The OTC pathway is depicted in the middle yellow column and the bottom left yellow diamond and oval of the decision tree.
We begin by knowing that the active ingredient is not an approved NDA or ANDA and need to ask, "Has the product's ingredient, strength, dosage form, route of administration, directions, etc., been reviewed under the OTC Drug Review?"