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PDP-716 FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 5, 2023.

FDA Approved: No
Brand name: PDP-716
Generic name: brimonidine tartrate
Company: Visiox Pharma, LLC
Treatment for: Glaucoma, Open Angle, Glaucoma/Intraocular Hypertension

PDP-716 (brimonidine tartrate 0.35%) is a once-daily ophthalmic formulation of the approved alpha adrenergic agonist brimonidine in development for the treatment of ocular hypertension and open angle glaucoma.

Development timeline for PDP-716

Jul 13, 2023FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility
Dec  8, 2022Visiox Pharma Announces FDA Acceptance of New Drug Application for Glaucoma
Oct  6, 2022Visiox Pharma Submits New Drug Application Seeking Approval for First Once-Daily Brimonidine for Glaucoma

Further information

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