People are often surprised when I tell them that 505(b)(2) applications can contain a new molecular entity (NME). In fact, a 505(b)(2) covers any NDA application that relies on pivotal efficacy or safety information that the sponsor does not own the rights to. So what is an NME?
Under FD&C 505(c)(3)(D) and 505(j)(5)(D) “a new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act. An active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.” Similarly, CFR 316.3(b)(13)(i) defines the “same drug” as a drug composed of small molecules, a drug that contains the same active moiety as a previously approved drug and is intended for the same use as the previously approved drug, even if the particular ester or salt….”
We have previously referred to the 100’s of DESI drugs that FDA has declared unapproved new drugs. Many of the actives in these drugs have never been approved in the U.S. Yet many, if not most of the active ingredients have some toxicology, pharmacokinetics and even clinical information in the public domain. FDA will treat these as NME’s. The good news is that approval of an NME gets 5 years of marketing exclusivity.