Requests that the FDA engage with Takeda Pharmaceuticals and advocate for the continued availability of Soticlestat for individuals diagnosed with CDKL5 Deficiency Disorder (CDD) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-0430

Requests that the FDA engage with Takeda Pharmaceuticals and advocate for the continued availability of Soticlestat for individuals diagnosed with CDKL5 Deficiency Disorder (CDD)

Documents

Comments

377

Description

CLOSED

Key Dates

Comment Period OpensFeb 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Jainu Jogani	Mar 4, 2026	--

Comment Statistics

Total Comments

377

Keywords

CDER

Citizen Petition

Requests that the FDA engage with

Takeda Pharmaceuticals and advocate for the

continued availability of Soticlestat for

individuals diagnosed with

CDKL5 Deficiency Disorder (CDD)

CLOSED

Data from Regulations.gov