> ## 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.

# Romark Seeks BE Restrictions on Alinia Generics
- URL: https://www.fdaweb.com/romark-seeks-be-restrictions-on-alinia-generics/
- Published: 2020-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:01:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146026

Romark Laboratories, which manufactures and distributes Alinia (nitazoxanide) tablets for oral use and for oral suspension, indicated for treating some cases of diarrhea, is asking FDA not to approve any ANDA for a generic form of its products unless the applicant satisfies bioequivalence provisions proposed by Romark. The company’s [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-0513-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says ANDA applicants should be required to conduct: 

- bioequivalence studies of both active metabolites, tizoxanide and tizoxanide glucuronide, in plasma under fasted and fed conditions;
- bioequivalence studies with clinical endpoints (regardless of whether the proposed generic product is quantitatively and qualitatively the same as the reference-listed-drug; and
- two bioequivalence studies with clinical endpoints, one each in subjects with *Giardia lamblia* and *Cryptosporidium parvum*.

The petition says such requirements are necessary because the product raises complicated and important scientific and legal issues. The company also asks that FDA revise its draft guidances on nitazoxanide tablets and oral suspension to incorporate the above-listed criteria to ensure bioequivalence.