Requests that the FDA take the following actions: 1. Decline to accept or approve any ANDA or section 505(b)(2) application referencing or relying upon ACETADOTE with labeling that omits the information in ACETADOTE’s prescribing information relating to a two-bag dosing regimen and the associated reduction in risk of hypersensitivity reactions | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-6019

Requests that the FDA take the following actions: 1. Decline to accept or approve any ANDA or section 505(b)(2) application referencing or relying upon ACETADOTE with labeling that omits the information in ACETADOTE’s prescribing information relating to a two-bag dosing regimen and the associated reduction in risk of hypersensitivity reactions

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response from FDA CDER to Cumberland Pharmaceuticals Inc.	May 5, 2026	--

Keywords

CDER

Citizen Petition

Cumberland Pharmaceuticals Inc.

Requests that the FDA take the following actions

1. Decline to accept or approve any ANDA or

ection 505(b)(2) application referencing or

relying upon ACETADOTE with labeling that omits

the information in ACETADOTE’s prescribing

Data from Regulations.gov