CBER Sends Untitled Letter to Marketer of Unapproved Allergy Spray

Regulatory NewsRegulatory News | 16 October 2018 |  By 

The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) sent an untitled letter to the owner of two websites purporting to sell allergy treatments that have not been approved.
The company Telogenes, LLC boasts that its product, known as Ollereg, “contains FDA-approved allergens used off label for oral immunotherapy,” among other claims, but FDA raised concerns.
“Based on these statements, it appears that your product is intended to treat and/or prevent allergies in adults or children, and therefore appears to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease… Your product is not the subject of an approved biologics license application (BLA), nor is there an IND in effect involving your product. Based on this information, your actions violate the FFD&C Act and the PHS Act.”
FDA requests that the firm notify it in writing of steps taken to address the violations cited by the agency.
This is the ninth untitled letter that CBER has sent so far in 2018.
Untitled Letter


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