September 15, 2008
Lundbeck Files NDA in US for Schizophrenia Drug
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.
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.
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."