Requests that prior to granting full approval, the FDA take immediate administrative action requiring all Abbreviated New Drug Application (ANDA) holders of the powerful pulmonary drug nintedanib to undergo control and monitoring for N-nitrosamine Drug Substance-Related Impurities (NDSRIs) in all generic formulations | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5582

Requests that prior to granting full approval, the FDA take immediate administrative action requiring all Abbreviated New Drug Application (ANDA) holders of the powerful pulmonary drug nintedanib to undergo control and monitoring for N-nitrosamine Drug Substance-Related Impurities (NDSRIs) in all generic formulations

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 24, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to AdventaPharma DWC-LLC	Mar 23, 2026	--

Keywords

CDER

Citizen Petition

AdventaPharma DWC-LLC

Requests that prior to granting full approval,

the FDA take immediate administrative action

requiring all Abbreviated New Drug Application

(ANDA) holders of the powerful pulmonary drug

nintedanib to undergo control and monitoring for

Data from Regulations.gov