Request the FDA to rescind approval of VEVYE (cyclosporine ophthalmic solution) 0.1%/NDA 217469 due to violation of CFR§314.25(b)(5) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5831

Request the FDA to rescind approval of VEVYE (cyclosporine ophthalmic solution) 0.1%/NDA 217469 due to violation of CFR§314.25(b)(5)

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 4, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response to Triple Gate Capital, LP	Apr 28, 2026	--

Comment Statistics

Total Comments

Keywords

CDER

Citizen Petition

Triple Gate Capital, LP

Request the FDA to rescind approval of

VEVYE (cyclosporine ophthalmic solution)

0.1%/NDA 217469 due to violation of

CFR§314.25(b)(5)

Open

Data from Regulations.gov