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KPI-121 0.25% Approval Status

FDA Approved: No
Brand name: KPI-121 0.25%
Generic name: loteprednol etabonate
Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

KPI-121 0.25% (loteprednol etabonate) is an ophthalmic corticosteroid formulation in development for the temporary relief of signs and symptoms of dry eye disease.

Development Status and FDA Approval Process for KPI-121 0.25%

Aug  8, 2019Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
Dec 26, 2018Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration
Oct 16, 2018Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for KPI-121 0.25% for Dry Eye Disease

Further information

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