Novel drugs are new therapeutic options that expand our healthcare system, allowing for the treatment of more diseases to address unmet public health needs. These newly synthesized drugs are also referred to as New Molecular Entities (NMEs). They contain active moieties that have not yet been identified or approved by the FDA. The term “active moieties,” refer to the part of a molecule or ion that is responsible for the physiological or pharmacological action of the drug.
Although NMEs and “new chemical entities” (NCEs) may sound similar, they are different. Unlike NMEs, NCEs refer to drugs that do not contain active moieties that have been approved by the FDA in any other New Drug Application (NDA). In other words, these drugs do not have a single approved moiety. Generally, an NCE is a molecule created in the early stages of drug development that could potentially become a useful drug, while an NME is a compound of molecules discovered during drug development.
For examples of novel drugs, visit the novel drugs page on the FDA site. Under the New Molecular Entity and New Therapeutic Biological Product Approvals (CDER only) section, you’ll find novel drug approvals within the last 4 years. The Orange Book Database contains information on all FDA-approved drug products as well as patent and exclusivity information. It consists of four main parts including The Prescription Drug Product List, The OTC Drug Product List, The Drug Products with Approval under Section 505 of the FD&C Act Administered by the Center of Biologics Evaluation and Research List, and The Discontinued Drug Product List.