The USP says a new nomenclature scheme for salt drug substances will make for consistent product naming and ultimately help drugmakers.
The new naming system – which will become official on May 1 next year – requires that products formulated with a salt of an acid or base will use the active moiety—the clinically active part of the drug—in the title of a monograph.
Under US law, monograph titles - such as ‘atorvastatin calcium’ for Pfizer’s Lipitor – are used to distinguish drugs from the brand names for a variety of reasons, from providing doctors and nurses with a common reference to allowing drugmakers to protect their trademarks.
The new policy also dictates that the strength of the drug will be expressed in terms of its active moiety, not its salt form.
USP CEO Roger Williams said: “The development of USP’s Monograph Naming Policy is designed to provide concise and consistent names for drug products,” adding that “consistency in drug product names ultimately will benefit manufacturers, regulators, practitioners, and most importantly, patients.”
The scheme will be applied to existing monographs unless there is a ‘justifiable’ need to maintain the current name, such as when the inclusion of the specific salt form provides vital information from a clinical perspective or if the strength is expressed in terms of the salt for historical reasons.
Before May, drugs without a monograph will be considered on a case-by-case basis, according to the USP which said it will accept Interim drug names approved by FDA for USP dosage form monograph titles that are proposed or implemented before May 1, 2013.
After the introduction date the naming policy will be applied to all drug products without monographs.For drugs that are not approved on May the USP advises that manufacturers contact the Food and Drug Administration (FDA) as soon as possible to consider the implications of the policy.
Williams said that: “Because of the prospective nature of the policy, we do not anticipate many changes in the names of existing products, which would be confusing to patients and practitioners. Rather, the changes will occur prospectively over time.”