Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Antipsychotic Labels Will Highlight Need For Proper Diagnoses Of Bipolar Kids

Executive Summary

The Highlights section of labeling for three atypical antipsychotic drugs with sNDAs for pediatric indications pending at FDA would emphasize the importance of correctly diagnosing bipolar disorder, Office of Drug Evaluation I Director Bob Temple said at a recent advisory committee meeting

You may also be interested in...

Long Term Antipsychotic Use In Kids Okay With FDA, But Panel Has Concerns

Not only did three antipsychotic drugs receive FDA advisory committee endorsement June 10 for the acute treatment of schizophrenia and bipolar disorder in pediatric populations, but FDA said that if the sNDAs are approved, it will likely extrapolate pediatric maintenance claims from the adult data

Unmet Need Justifies Risks For Pediatric Use Of Antipsychotics, FDA Advisory Committee Says

Panel’s votes on the safety of AstraZeneca’s Seroquel, Lilly’s Zyprexa and Pfizer’s Geodon to treat pediatric schizophrenia and bipolar disorder indicate that the severity of the conditions and need for additional treatments justify the known risks.

Opening Product Labeling To Broader CE Data Is Proposed In Senate Bill

Drug product labels could contain an array of comparative effectiveness data beyond well-controlled clinical trials, if Sens. Jack Reed, D-R.I., and Barbara Mikulski, D-Md., get their way


Latest News
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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