Naming of Drug Products Containing Salt Drug Substances; Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Naming of Drug Products Containing Salt Drug Substances" which replaces the draft guidance of the same title that published on December 26, 2013. This guidance describes the United States Pharmacopeia's (USP's) "Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations," which became official on May 1, 2013, and how the Center for Drug Evaluation and Research (CDER) is implementing it.