First Approval Of P&U's Reboxetine

As reported briefly in the Marketletter last week, Pharmacia & Upjohnhas received marketing authorization from the UK Medicines Control Agency for Edronax (reboxetine) for the treatment of depressive illness. This is the first approval for the drug worldwide.

The UK will act as the reference state for further approvals throughout the European Union. Separate applications have also been filed in Switzerland and Italy, while in the USA, Phase III trials of the drug are still ongoing. A spokeswoman for the company told the Marketletter that a launch in the UK is anticipated sometime in the summer. Pricing has not yet been established. The drug will be made available in 4mg scored tablets, and the recommended dosage is 8mg/day, rising to a maximum recommended level of 10mg/day.

Noradrenaline Reuptake Inhibitor Reboxetine is a selective noradrenaline reuptake inhibitor, and will probably be positioned as an alternative to the selective serotonin reuptake inhibitors in detailing to doctors. P&U said it had not yet made a decision on how it would promote reboxetine to the medical profession.