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# Curex Marketing Unapproved Allergy Drops: FDA
- URL: https://www.fdaweb.com/curex-marketing-unapproved-allergy-drops-fda/
- Published: 2021-04-07T12:00:00.000Z
- Updated: 2026-09-14T16:53:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149058

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Curex, Inc., New York, NY, determined that the firm markets mixtures of allergenic extracts intended for sublingual immunotherapy. A 3/23 [Notice of Violation](https://www.fda.gov/media/147356/download?ref=fdaweb.com) says the Web site refers to the products as “allergy drops” and “drop compounds.”

The notice says the allergy drops and drop compounds are legally considered to be drugs and biological products that require a valid BLA or IND to be lawfully marketed. Curex has neither form of approval, CBER says, and thus the marketing and distribution of the products appear to violate the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

The letter requested a written response within 30 days.