Monograph vs. New Drug Application (NDA) for Marketing Approval

Drug products that do not meet the specific monograph criteria are subject to approval through a New Drug Application (NDA). For an NDA, extensive data packages (e.g., clinical efficacy, pharmacology and toxicology data) must be submitted for FDA review to establish the drug’s safety and efficacy to receive marketing approval. Important characteristics of NDA and monographed drugs are presented in Table 2.4

Table 2. NDA and monograph pathways: Key regulatory differences in these processes are highlighted.
NDAMonograph
Product specificActive ingredient specific
Process seeks FDA premarket approval.FDA premarket approval not required if monograph conditions met.
Product changes may require additional FDA approval.Changes within monograph conditions require no FDA approval.
Labeling is unique to approved drug product.Labeling is the same for all similar products.
Possible marketing exclusivity.No marketing exclusivity; monograph is open to everyone.

If a product contains a drug not included in the monograph, it must be approved through the NDA process. Even if the drug is included in the monograph but is being used at a different dose, for a new indication, or in combination with another drug (dual-active product) not specified in the monograph, the product is subject to NDA approval. For example, triclosan is an antibacterial ingredient that is not included in the Antiplaque-Antigingivitis Monograph. Colgate® Total®, a fluoride dentifrice containing triclosan, required approval through an NDA before it could be marketed in the US as an antibacterial dentifrice that treats gingivitis.

Despite their differences, both NDAs and monographs for OTC medicines have very similar standards for safety and efficacy.4