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Home Industry News Lundbeck to work with FDA on Serdolect review

Lundbeck to work with FDA on Serdolect review

26th June 2009

Lundbeck is committed to working with the Food and Drug Administration (FDA) to complete the review of Serdolect (sertindole), it has stated.

The company has received a complete response letter from the regulatory body about its schizophrenia treatment.

Included in the document was a request for additional information to understand which patient population could benefit the most from the medication.

Over the coming months, Lundbeck will collaborate with the FDA to ensure a conclusion of the review is met quickly.

“[We are] ? currently evaluating the feedback ? and will work with the agency to resolve these outstanding questions and discuss appropriate next steps required to bring Serdolect safely to market,” the company asserted.

As well as having an inhibitory effect on alpha-adrenergic receptors, the drug has an impact on central dopamine D2 and serotonin 5-HT2 receptors.

Studies of the therapy have shown it does not have a sedative outcome in patients.

Lundbeck reported last month it had not received an action letter from the FDA about its Serdolect drug application, adding it had been assured it would receive information as soon as possible.

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