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Vyzulta Approval History

FDA Approved: Yes (First approved November 2, 2017)
Brand name: Vyzulta
Generic name: latanoprostene bunod
Dosage form: Ophthalmic Solution
Previous Name: Vesneo
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Vyzulta (latanoprostene bunod) is a nitric oxide donating prostaglandin receptor agonist for the treatment of patients with open angle glaucoma or ocular hypertension.

Development History and FDA Approval Process for Vyzulta

DateArticle
Nov  2, 2017Approval FDA Approves Vyzulta (latanoprostene bunod) Ophthalmic Solution for Open-Angle Glaucoma, Ocular Hypertension
Aug  7, 2017Valeant Pharmaceuticals Receives Complete Response Letter from the FDA for Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA
Mar 20, 2017Bausch + Lomb And Nicox Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene Bunod
Feb 27, 2017Bausch + Lomb And Nicox Resubmit US New Drug Application For Novel Glaucoma Candidate Latanoprostene Bunod
Jul 22, 2016Valeant Pharmaceuticals Receives FDA Complete Response Letter for Latanoprostene Bunod
Sep 22, 2015Bausch+Lomb and Nicox Announce FDA Acceptance of NDA for Novel Glaucoma Candidate Vesneo (latanoprostene bunod)

Further information

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