DRUG DISCOVERY DEVELOPMENT (DDD): Drug Classification System

All new drugs filed with the FDA are given a classification that characterizes its chemical type and the expected therapeutic gain.

Question

Drug Classification System

All new drugs filed with the FDA are given a classification that characterizes its chemical type and the expected therapeutic gain.

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Type 1 – new molecular entity 
Type 2 – new salt 
Type 3 – new formulation 
Type 4 – new combination 
Type 5 – already marketed drug product – marketed by other firm 
Type 6 – already marketed drug product by the same firm

DRUG DISCOVERY DEVELOPMENT (DDD)

Drug Classification System All new drugs filed with the FDA are given a classification that characterizes its chemical type and the expected therapeutic gain.

Type 1 – new molecular entity Type 2 – new salt Type 3 – new formulation Type 4 – new combination Type 5 – already marketed drug product – marketed by other firm Type 6 – already marketed drug product by the same firm

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