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Published on 29 June 2009

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Lundbeck receives FDA Complete Response Letter


Lundbeck announced that the company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Serdolect (sertindole) for the treatment of schizophrenia.

The Agency’s complete response included request for additional data to best understand the appropriate patient population for which Serdolect could be made available.

Lundbeck is currently evaluating the feedback from FDA and will work with the Agency to resolve these outstanding questions and discuss appropriate next steps required to bring Serdolect safely to market.

In the coming months Lundbeck is committed to addressing the FDA’s CRL and will work with the Agency to expedite completion of its review.


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