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


Namenda "not approvable" for mild-moderate Alzheimer’s

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Forest's Namenda (memantine) is "not approvable" for treatment of mild-to-moderate Alzheimer's disease, the firm says July 25. Two studies failing to show statistical significance led FDA to deny the indication. The sNDA included a third study showing statistical significance, but "FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies," Forest said. Namenda would have been the first AD agent approved for the full continuum of the disease. J&J's Risperdal (risperidone) also was deemed not approvable recently for an Alzheimer's-related indication (1Pharmaceutical Approvals Monthly June 2005, p. 13)...

You may also be interested in...

J&J Risperdal “Not Approvable” For Autism, Alzheimer’s Psychosis

Johnson & Johnson is considering how to proceed with Risperdalafter two supplemental applications for new indications for the atypical antipsychotic have been deemed "not approvable" by FDA

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.





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