FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Antera Therapeutics Receives Untitled Letter for Selling Unapproved Biologic

Nov. 30, 2016

Antera Therapeutics has drawn FDA scrutiny for marketing and selling Aralyte, a kit of capsules filled with liquid peanut protein, as a preventative treatment to keep children from developing peanut allergies.

In an untitled letter, the FDA said Antera Therapeutics makes unsubstantiated claims about its product, Aralyte. The claims include that Aralyte is “intended to reduce the risk of allergy development in children who are not allergic” and that it’s “designed to help the body process the peanut allergen in the most safe and effective way.”

Additionally, the FDA pointed to its claims that Aralyte is manufactured “to be maximally effective in allergy prevention and with your family’s safety.

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