Requests that the FDA make a determination that the proposed drug product Prucalopride Orodispersible Films 1 mg and 2 mg, is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4391

Requests that the FDA make a determination that the proposed drug product Prucalopride Orodispersible Films 1 mg and 2 mg, is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensApr 21, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	May 6, 2026	--

Keywords

CDER

Suitability Petition

Pilnova Pharma Inc

determination that the proposed drug product

Prucalopride Orodispersible Films 1 mg and 2 mg

is suitable for submission

in an Abbreviated New Drug Application

OPEN

Data from Regulations.gov