GxP Perspectives

Have you ever wondered why drugs can have so many names and who keeps track of it all? It turns out that there are a number of different organizations that have some responsibility in the naming of drug products and it can be pretty confusing. Fortunately we have a Guest Commentary by Louise Johnson to help make sense of it all. Louis sent this out to her email informational list a few weeks ago and I pleaded with her to use it on the Blog. This is her second Guest Commentary after her popular “Ten Tips for Filing Regulatory Submissions.” I know I could have used Louise when I was auditing some cardiology studies that had a host of prohibited concomitant medications, all described differently. So here is a post you can bookmark for future reference. Louise’s list of how many names of drug products is pretty extensive.

Guest Commentary:

There are several types of names commonly used for drugs and biologics. Some names, such as the trade name, are selected by the sponsor, while others are assigned by nomenclature bodies. What are the different types of names and who selects them?

The chemical name is assigned following rules defined by the International Union of Pure and Applied Chemistry (IUPAC). The US national committee under IUPAC is the National Academy of Sciences. While there may be more than one chemical name in use, the IUPAC name is considered the official chemical name. The chemical name is included in the Description section package insert for small molecules.

The generic name (also referred to as the nonproprietary name or the common name) is selected by the United States Adopted Names (USAN) Council. USAN is sponsored by the American Medical Association, the US Pharmacopeial Convention, and the American Pharmacists Association and works with the international organization, the International Nonproprietary Name (INN) Programme of the World Health Organization (WHO). Sponsors can suggest a generic name and apply to USAN for adoption. USAN can reject the proposed name and suggest alternatives. Once the sponsor has accepted the proposed USAN name, USAN requests an INN from the WHO. The INN Programme can also reject the name and suggest alternatives. Upon final agreement, USAN adopts the name, informs the sponsor, and publishes the name on their website. FDA accepts the USAN name as part of NDA or BLA approval. Approval may be delayed if a simple and useful nonproprietary name does not exist and if one is not proposed in the application. The generic name must be included in all product labeling as part of the product name.

The established name is the name accepted by FDA for official use and is the name listed in the USP. The established name is usually the same as the USAN generic name, but FDA does have the authority to reject the name if it is not simple and useful. Note that an established name is also defined for the drug product following USP conventions. The established name is used in all official monographs and legal documents.

The trade name (also referred to as the proprietary name) is proposed by the sponsor and approved by FDA. The trade name is owned by the sponsor, is protected as intellectual property, and is trademarked. Trade names may not imply benefit and must be distinct from trade names of products already on the market in order to avoid product mixups. FDA has recently provided Guidance for Industry on trade name review. When the trade name is used in product labeling, it must be accompanied by the generic name. While the other names can be used by multiple companies for different products, the trade name is used only by the innovator company.

The trivial name is an acronym or shorthand version of the generic name that is often used in research papers, protocols, or reports. The trivial name has no legal status and is not an approved name.

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By Louise Johnson, M.S.
Senior Consultant, Regulatory Affairs
Biologics Consulting Group

Read Louise’s previous Guest Commentary Ten Tips for Filing Regulatory Submissions

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

And still another Update: Now you too can contribute to FDA history by suggesting an acronym to the Agency. I kid you not. FDA has a link where you can suggest a new acronym or abbreviation for the Agency’s use.

FDA Acronyms

Bioresearch Monitoring Information System: This FDA system with information on FDA BIMO inspections is updated quarterly. The latest update has been released with info on Q2 inspections.

GxP Perspectives LinkedIn Group

This entry was posted on Friday, July 2nd, 2010 at 8:22 AM and is filed under Commentaries by Guest Writers. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.