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Zerviate Approval History

FDA Approved: Yes (First approved May 30, 2017)
Brand name: Zerviate
Generic name: cetirizine hydrochloride
Dosage form: Ophthalmic Solution
Company: Nicox Ophthalmics, Inc.
Treatment for: Conjunctivitis, Allergic

Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.

The approval of Zerviate was based on efficacy data from three randomized, double-masked, placebo-controlled clinical trials in patients with a history of allergic conjunctivitis. Zerviate demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.

Zerviate is an ophthalmic solution administered as a single drop into the affected eye twice daily. Common side effects include eye redness (ocular hyperemia), pain at instillation site, and reduced clarity of vision (visual acuity).

Development History and FDA Approval Process for Zerviate

DateArticle
May 31, 2017Approval Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24%
Apr 11, 2017Nicox Announces PDUFA Date for Zerviate NDA
Mar  9, 2017Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDA
Oct 10, 2016Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170
Jun 21, 2016U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application
Apr 19, 2016Nicox submits New Drug Application for AC-170 to U.S. FDA

Further information

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