Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Lundbeck receives "complete response" from FDA for its schizophrenia drug

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA sends Lundbeck a "complete response" letter for its schizophrenia agent Serdolect (sertindole), reaching the same conclusion as its advisory committee: the atypical antipsychotic could be approved if Lundbeck can identify an appropriate patient population. Sertindole is clearly efficacious, but it also clearly has significant cardiovascular risk. The letter, announced June 25, requested "additional data to best understand the appropriate patient population for which Serdolect could be made available." At its April 7 review, the Psychopharmacologic Drugs Advisory Committee voted that, despite its lack of safety, the antipsychotic could be used in an acceptably safe manner in some patient groups (1"The Pink Sheet," April 13, 2009). But the panel couldn't pinpoint who those patients are, and so far neither can Lundbeck and FDA. Serdolect's user fee date was May 15

You may also be interested in...

FDA Complete Response Slows Down, But Won't Stop, Lundbeck's Serdolect

Agency comes to same conclusion as advisory committee: the risky schizophrenia drug could get approved if an appropriate patient group is identified.

DuPont, P&G Aim To Accelerate Probiotic Sales By Developing ‘Next Generation’ Ingredients

DuPont says it and P&G “have conducted extensive research on human commensals bacteria to help address metabolic health issues in humans.” The partnership "will help us further advance our probiotic innovation via a next generation solution that will prove beneficial to the health and well-being of consumers around the world,” says Paul Gama, P&G personal health care president.

Head & Shoulders' ‘100%’ Ad Campaign Continues Competition Between Mahomes, Polamalu

Head & Shoulders airing a 30-second TV spot featuring Kansas City Chiefs quarterback Patrick Mahomes and former Pittsburgh Steelers safety Troy Polamalu competing over who gives “100%” effort in everything they do.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts