Aurobindo Pharma Limited (Reuters Code: ARBN.BO) is delighted to announce that it has received the marketing authorization approval from Medicines Evaluation Board (MEB), NETHERLANDS for Mirtazapine 15, 30 and 45 mg orally disintegrating tablets containing the active ingredient Mirtazapine.
This is the second formulation approval received from MEB, NETHERLANDS for a product developed in house by Aurobindo, and fourth such approval in Europe as a whole. With this approval, it will be easier for Aurobindo to obtain similar marketing authorization for Mirtazapine OD tablets in the other countries of the European Union through Mutual Recognition Procedure.
Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity.
Mirtazapine enjoys a market of over 140 mio Euros in Europe. 90% of this market is with orally disintegrating form of tablets. Aurobindo has already filed 20 products in various EU countries, some of which are nearing the marketing authorization approvals. Many more filings in the EU countries are in pipeline in the coming year.
