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A-Z Fundamentals of Dentifrice: Oral Health Benefits in a Tube

Course Number: 670

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

The second pathway is through a New drug application (NDA), which is used for new drug products that fall outside the range of ingredients already included in the OTC Monograph system, as above. NDAs for dentifrices are uncommon and require the manufacturer to demonstrate that the product is safe and effective through comprehensive clinical testing. Examples include extensive data packages (e.g., clinical efficacy, pharmacology and toxicology data) which must be submitted for FDA review to establish the drug’s safety and efficacy to receive approval to market as therapeutic. Important characteristics of NDA versus monographed drugs are presented in Table 2.6

If a product contains an ingredient or 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, 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 and therefore underwent NDA approval. Despite their differences, both NDAs and monographs for OTC medicines have very similar standards for safety and efficacy.6

Table 2. NDA and Monograph Pathways: Key Regulatory Differences in These Processes Are Highlighted.

Product specific. Active 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.