A Drug with No Name – Can One Be Approved?

Not long ago, a colleague asked my opinion as to whether or not a drug or biologic could be approved by the FDA even though it still lacked a trade name.  Upon thinking about it, I could recall instances where an approval was held up for a product pending the final trade name for the product.  Based on that, my sometimes faulty sense of logic led me to deduce that the trade name must be considered part of the label and therefore must be resolved prior to approval.

That notion was seriously challenged when I saw yesterday a release by AstraZeneca that announced the assignment of a trade name to a product that had been already approved – “AstraZeneca Announces Trade Name Caprelsa for vandetanib“.  According to the release vandetanib was approved by the FDA on April 6, 2011 and AstraZeneca made the product available to U.S. patients before it received a trade name.

“We chose to launch the drug as vandetanib without waiting for a trade name approval because there were no other FDA-approved medicines available for people with this rare type of thyroid cancer,” said Eric Vogel, Executive Director of Oncology.

So there it was, alas, I was wrong.

That led me to inquire of FDA about the matter and they confirmed that indeed, it is possible, though unsual, for an NDA to get approval without the trade name.  My thanks to the folks at the public affairs office who supplied the following clarification:

Companies are not required to have a proprietary name for their products.  However, when a proprietary name is submitted, FDA strives to approve proprietary names (also referred to as “tradenames”) at the time of NDA, BLA, ANDA approval.  Occasionally, applications are approved using only the established name.  This occurs frequently with ANDA products, which may never use a proprietary name in marketing, and infrequently with NDA or BLA products.  When drugs are approved using the established name, a company may elect to submit a labeling supplement to the application post approval for a Proprietary Name Request. The supplement must also include all associated labeling that contains  the proposed proprietary name.

I am also given to understand that it is also possible for a horse to have no name.

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One Response to A Drug with No Name – Can One Be Approved?

  1. Ron Rader says:

    There are many examples of biopharmaceuticals/biologics receiving full original BLA approvals without any company-selected name, with the company just using the USAN or a name adopted by FDA (if the sponsor or no one else bothered to pay to get a USAN or INN). For example, there are various vaccines, mostly non-mainstream ones, with no trade names, and probably the great majority of blood/plasma-derived products lack trade names, e.g., no one bothers to brand such products as various human immune globulins [e.g., Hepatitis B Immune Globulin (Human)], antitoxins/antivenins (e.g., aninimal-derived immunoglobulin snake bite treatments), or various human Factor VIII/hemophilic fractions, Leukocytes, Red Blood Cells, etc. And there are also many precedents for biologics’ intermediates, such a bulk recombinant proteins, vaccines destined to become components of combination vaccines, etc., that receive their own full BLAs.

    For those interested in pharmaceutical nomenclature issues, see an article I authored, “Nomenclature of Biosimilars Will Be Highly Controversial,” from the June issue of BioProcess International online at http://www.biopharma.com/biopharmacopeia/BPI_Biosimilars_article_6.2011.pdf. Product nomenclature for biosimilars could well be as contentious issue as biosimilars themselves and biosimilar data exclusivity were, since the official nonproprietary (established) names to be used for prescriptions and marketing will largely control health care professionals’ and consumers’ views of these products — e.g., are the names and products fully unique or are similarities and relationships between products indicated by names?; what type(s) of similarities should be indicated in names and how?; how much are the biosimilars (as indicated by their names) like generic drugs and to be presumed low-end and best avoided, if possible?.  And of course, names, whether unique or not, (bio)similar or not, etc., will determine product marketing, e.g. ,with biosimilar names facilitating biosimilar sales (and also unofficial substitution), while fully unique names will require biosimilars to be marketed much the same as innovator products and will make substitution more difficult.