> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Untitled Letter on Unapproved Biologic
- URL: https://www.fdaweb.com/fda-untitled-letter-on-unapproved-biologic/
- Published: 2016-11-21T12:00:00.000Z
- Updated: 2026-09-14T21:49:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137392

FDA has sent Antera Therapeutics an [untitled letter](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM529997.pdf?ref=fdaweb.com) due to promotional claims on the company’s Web site that make Aralyte Starter Kit an unapproved biological product. Aralyte is described as an all natural peanut protein formula. Claims on the Web site demonstrate that the product is intended to prevent peanut allergy from developing in children, the FDA letter says. It also notes that the product does not have an approved BLA or IND on file.