Requests that the FDA to revoke the approval of, or require the reformulation of, all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for rectal suppository formulations of indomethacin that contain the excipient butylated hydroxytoluene. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-7377

Requests that the FDA to revoke the approval of, or require the reformulation of, all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for rectal suppository formulations of indomethacin that contain the excipient butylated hydroxytoluene.

Documents

Comments

Key Dates

Comment Period OpensDec 29, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response to Wiley Rein LLP	Jun 25, 2026	--

Keywords

CDER

Citizen Petition

Wiley Rein LLP

to revoke the approval of

or require the reformulation of

all New Drug Applications and

Abbreviated New Drug Applications for rectal

suppository formulations of indomethacin that

Data from Regulations.gov