Requests that the FDA issue a Complete Response Letter to NDA 216442 (Reproxalap Ophthalmic Solution) due to failure to meet requirements under CFR§314.25(b)(5) to provide substantial evidence that the drug will have the effect purported under the conditions of use prescribed in the proposed labeling | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5713

Requests that the FDA issue a Complete Response Letter to NDA 216442 (Reproxalap Ophthalmic Solution) due to failure to meet requirements under CFR§314.25(b)(5) to provide substantial evidence that the drug will have the effect purported under the conditions of use prescribed in the proposed labeling

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 30, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Triple Gate Capital, LP	Apr 22, 2026	--

Comment Statistics

Total Comments

Keywords

CDER

Citizen Petition

Triple Gate Capital, LP

Requests that the FDA to issue a

Complete Response Letter to NDA 216442

(Reproxalap Ophthalmic Solution) due to failure

to meet requirements under CFR§314.25(b)(5)

to provide substantial evidence that the drug

Data from Regulations.gov