Aurobindo gets second MHRA approval in UK for mirtazapine tablets

Aurobindo Pharma Ltd has announced that it has received the marketing authorisation approval from the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) for mirtazapine 15, 30 and 45mg tablets containing the active ingredient mirtazapine.

This is the second formulation approval received from the UK MHRA for a product developed in house by the company. With this approval, it will be easier for Aurobindo Pharma to obtain similar marketing authorisation for Mirtazapine tablets in the other countries of the European Union through mutual recognition procedure. This generic product is bio-equivalent and has the same therapeutic effect to the innovator product, namely Zispin of Organon Inc.

Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity and enjoys a market of over $140 million in Europe.

Aurobindo Pharma 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.

Mill Pharm, the company''s wholly owned subsidiary has over 100 market authorisations in Europe.