Esters and Salts and Moieties, Oh My! Section 505 of the Federal Food, Drug, and Cosmetic Act provides several kinds of exclusivity for drugs containing an active ingredient (including any ester or salt of the active ingredient) that the agency has not previously approved under the Act. FDA’s regulations refer to previously approved active moieties. What is the significance of esters and salts? What is an active moiety?
Using the framework of FDA’s articulated structure-based approach for determining active moieties, this webinar will lay out the basic principles of organic chemistry that go into determining a drug product’s active moiety. We will discuss the difference between ionic and covalent bonds, how to identify them in a molecular structure, and how they impact a product’s status as a new chemical entity for exclusivity purposes. In addition, we will discuss how differences in molecular structure influence decisions to file a 505(b)(2) versus a 505(j) application for certain products. Finally, we will discuss the chemistry behind racemates and enantiomers, prodrugs, and polymorphs and the related regulatory implications of these different types of molecules. This webinar will provide a baseline of information for those who work or practice in the pharmaceutical field and may be asked to review NDAs or comment on potential exclusivity determinations, but do not have a background in chemistry.
Sanjay Sitlani, Senior Regulatory Counsel, Office of Regulatory Policy, CDER, FDA
Steven G. Davis, Partner, McCarter & English LLP
Moderated by Rachel Turow, Executive Counsel — Regulatory Law, TEVA Pharmaceuticals USA, Inc.
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