Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Naming of Drug Products Containing Salt Drug Substances." The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling. The policy became official on May 1, 2013. This draft guidance describes the U.S.P. policy, discusses the Center for Drug Evaluation and Research's (CDER's) application of the policy, and recommends how CDER and industry can implement the policy.