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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