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Open for Comments
FDA-2025-P-5790
Requests the FDA to modify the Prescribing Information for TRYPTRYR (acoltremon ophthalmic solution) to conform to requirements of CFR 201.57(c)(2)(iv) and to state: “indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)“
Documents
3
Comments
0
Description
Open
Key Dates
Comment Period OpensNov 3, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Triple Gate Capital, LP
Requests the FDA to modify the Prescribing
Information for TRYPTRYR
(acoltremon ophthalmic solution) to conform to
requirements of CFR 201.57(c)(2)(iv) and to
state: indicated to increase tear production in
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