UK MHRA APPROVES AUROBINDO'S GENERIC ZISPIN

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Indian drugmaker Aurobindo Pharma marketing authorization for generic mirtazapine 15-, 30- and 45-mg tablets.

This is Aurobindo's second MHRA approval. With this approval, the company hopes to obtain similar marketing authorization for mirtazapine in the European Union through Mutual Recognition Procedure. This generic product is bioequivalent of Organon's Zispin.

Zispin is an antidepressant that exhibits both noradrenergic and serotonergic activity with a market of more than $140 million in Europe.

Aurobindo has already filed applications for 20 products in European countries, some of which are nearing the marketing authorization approvals.