FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OTC Sleep Drug Named After Antidepressant Is Misbranded and Misleading, Warns FDA

June 28, 2017
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The maker of an over-the-counter sleep aid has been warned by the FDA for marketing and branding a product with a name that may cause consumers to confuse it with an older prescription drug no longer on the market.

In addition to being considered an unapproved new drug, the warning letter sent to the makers of “Elavil OTC Sleep Aid” said it is too easily confused with the proprietary and established Elavil (amitriptyline) — AstraZeneca’s FDA-approved prescription drug for the treatment of depression.

Elavil OTC, made by Virginia-based Belmora, is a sleep aid made from natural ingredients, according to the medication’s website — and does not contain amitriptyline, a tricyclic antidepressant. Approved in the 1980s, prescription Elavil was commonly prescribed off-label for insomnia in the U.S. but has not been manufactured under that name since 2003, following the expiration of its patent.

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