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news.Lundbeck has announced that the FDA has completed the initial check for completeness and accepted the new drug application on Serdolect for the treatment of schizophrenia for review.
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Lundbeck said that this is the first new drug application (NDA) submitted in the US by the company, and it follows the launch of Serdolect in Europe, South and Central America, Asia and the Middle East.
According to the company, Serdolect is an effective antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extrapyramidal symptoms. Serdolect’s clinical and pharmacological profile indicates that the drug may improve their daily functioning and their quality of life and reduce the risk of relapse.
Anders Pedersen, head of Lundbeck’s drug development, said: “We are very pleased that we have submitted an NDA for Serdolect as this will potentially provide patients suffering from schizophrenia in the US with a new treatment option.”