Request that FDA refuse to approve the Lantheus NDA seeking approval of Ga-68 edotreotide injection unless and until Lantheus submits to FDA the results of certain testing | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-1222

Request that FDA refuse to approve the Lantheus NDA seeking approval of Ga-68 edotreotide injection unless and until Lantheus submits to FDA the results of certain testing

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensFeb 3, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	008_Lepareur 2022	Feb 3, 2026	--

Comment Statistics

Total Comments

Keywords

CDER

Curium US LLC

refuse to approve the Lantheus NDA

seeking approval of Ga-68 edotreotide

injection unless and until Lantheus submits

to FDA the results of certain testing

OPEN

Data from Regulations.gov