The FDA's approval of new drugs is mainly based on the chemical types and therapeutic potential of drugs.
Introduction to FDA:
According to chemical types, new drugs are mainly divided into:
1 class: a new molecular compound (NME). It has never been approved as a drug in America.
Or an active ingredient sold, which can be a single ingredient or a part of a stereoisomeric mixture;
The second category: new derivatives. Derived from active ingredients that have been listed (so-called "patented" drugs), that is, they have been listed in the United States.
Esters, salts or other non-valence bond derivatives of listed active ingredients, or parent compounds with modified groups are not allowed to be listed in the United States;
The third category: new preparations. New dosage forms or prescriptions containing active ingredients on the market,
Indications can be the same as or different from products on the market;
The fourth category: new combinations. There are two or more kinds of active ingredients in the market, but there is no such combination in the listed products;
The fifth category: imitation, imitation of other factories.
Products already on the market have the same active ingredients, formulas or combinations;
Category 6: New indications. Replicas with new uses approved or listed by the same company or other companies in the United States;
Category 7: Listed but not approved.
Drugs approved by NDA. Indications are the same as those of listed products, or they may be different;
Category 8: over-the-counter drugs;
Category 9: Application for new drugs with different indications.