> ## 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.

# Correct ‘Misleading’ AbbVie Study Description: Ali
- URL: https://www.fdaweb.com/correct-misleading-abbvie-study-description-ali/
- Published: 2024-09-03T12:00:00.000Z
- Updated: 2026-09-14T14:40:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157698

Ali Pharmaceutical Manufacturing, a subsidiary of American Laboratories, is asking FDA to require AbbVie to correct what Ali says is the misbranding of an investigational product in a thyroid study. The Ali [petition](https://downloads.regulations.gov/FDA-2024-P-4160-0001/attachment%5F1.pdf?ref=fdaweb.com) says AbbVie is not using Ali’s Armour Thyroid in a study “to assess the safety and efficacy of oral Armour Thyroid compared to synthetic for the treatment of primary hypothyroidism in adult patients.”

The petition says the AbbVie investigational product is a biologic that contains a novel active pharmaceutical ingredient that is different from the active ingredient in Armour Thyroid and thus is not Armour Thyroid.

Ali also asks that FDA take other appropriate actions to ensure that patients already enrolled and considering enrolling in the study, study investigators, and study staff are accurately

informed about the identity of the investigational product.

The petition says there is urgency in the matter since the study started on 4/26 with an intended enrollment of 2,800 patients and is currently enrolling patients at 107 locations in the U.S. “The risks of this investigational product, which has a very limited treatment history, may be different from the risks of a product that has been safely used by more than one million Americans over decades,” Ali says.