Lundbeck receives FDA Complete Response Letter on Serdolect 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.
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.