Data updated: Nov 8, 2026
PATANASE (olopatadine hydrochloride) · Novartis
Respiratory
Approved 2008-04-15
4
Indications
--
Phase 3 Trials
1
Priority Reviews
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-04-15
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
PATANASE Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2008 to 2021 · 3 indication expansions
Jul 2016 SUPPL
Mfg · Manufacturing (CMC)
Jun 2009 SUPPL
Efficacy
What PATANASE Treats
4 FDA approvalsOriginally approved for its first indication in 2008 . Covers 4 distinct patient populations.
- Other (4)
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01657240 | SOPH118-0112/III | Ph 3 | withdrawn | Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis |
| NCT01344083 | LT1210-PII-04/10 | Ph 2 | completed | Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PATANASE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.