Requests that the FDA take action to address the imminent public health risk posed by the presence of high levels of immunogenic impurities in generic Indomethacin Suppositories, USP 50 mg, marketed by Hikma Pharmaceutical USA Inc. under ANDA 215899 and Amneal Pharmaceuticals LLC under ANDA 215399 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-6089

Requests that the FDA take action to address the imminent public health risk posed by the presence of high levels of immunogenic impurities in generic Indomethacin Suppositories, USP 50 mg, marketed by Hikma Pharmaceutical USA Inc. under ANDA 215899 and Amneal Pharmaceuticals LLC under ANDA 215399

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 14, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CDER to Wiley Rein LLP	May 11, 2026	--

Keywords

CDER

Citizen Petition

Wiley Rein LLP

Requests that the FDA take action to address the

imminent public health risk posed by the

presence of high levels of immunogenic

impurities in generic Indomethacin Suppositories

USP 50 mg, marketed by

Data from Regulations.gov