Nicox holds successful pre-NDA meeting with FDA for AC-170

26 January 2015

French ophthalmics company Nicox (Euronext Paris: COX) has held a positive pre-New Drug Application meeting with the US Food and Drug Administration for AC-170.

AC-170 is a topical ocular formulation of cetirizine, developed to treat ocular itching associated with allergic conjunctivitis. The FDA meeting was designed to discuss the clinical package for AC-170, and based on the efficacy and safety data presented, the Agency recommended submission of the NDA. There will be an additional pre-NDA Meeting on the chemistry, manufacturing and controls data package, expected to take place in the first quarter of 2015.

Cetirizine is a second-generation histamine H1-receptor antagonist and a leading antihistamine which has been marketed for more than 25 years.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK