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# Bausch Health Wants Duobrii ANDA Restrictions
- URL: https://www.fdaweb.com/bausch-health-wants-duobrii-anda-restrictions/
- Published: 2021-06-17T12:00:00.000Z
- Updated: 2026-09-14T17:03:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149558

Bausch Health is petitioning FDA not to approve any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act that cites Duobrii as the reference-listed drug unless the application meets all the specifications sought by the company. The 5/28 [petition](https://downloads.regulations.gov/FDA-2021-P-0550-0001/attachment%5F1.pdf?ref=fdaweb.com) asks that the agency require, at a minimum, that all of the bioequivalence and pharmaceutical equivalence criteria in the document be satisfied for approval of an ANDA for a generic Duobrii. The criteria sought are: 

- Q1, Q2, and Q3 sameness of inactive ingredients;
- Corroboration by clinical endpoint bioequivalence study; and
- Successful HPA-axis suppression study.