Requests that the FDA declare that the drug product, Enzalutamide Oral Solution, 160 mg/5 mL is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5432

Requests that the FDA declare that the drug product, Enzalutamide Oral Solution, 160 mg/5 mL is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 16, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	Apr 27, 2026	--

Keywords

CDER

Suitability Petition

Pharmobedient Consulting LLC

declare that the drug product

Enzalutamide Oral Solution

160 mg 5 mL

is suitable for submission

in an Abbreviated New Drug Application

Data from Regulations.gov