Organon, the human health care business unit of Dutch drugs and chemicals firm Akzo Nobel, says it will file a New Drug Application for its novel antidepressant mirtazapine (known as Remeron in most countries) with Japanese regulators towards the middle of 2007, three years earlier than expected.
"This is very exciting news for us," said Emile van Dongen, executive vice president, global sales. "The Japanese market is an important market and we are confident that mirtazapine's fast onset of action and tolerability will make it a first-line option for depression in Japan," he said.
The noradrenergic and selective serotonergic antidepressant (NaSSA) has been available in other countries since 1994. According to Organon, it has a unique mechanism of action and has been proven safe and effective in the treatment of major depression in many countries. Organon's Japanese unit has been developing mirtazapine for depression in partnership with Meiji Seika Kaisha since 2004.
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.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze