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

UsernamePublicRestriction
UsernamePublicRestriction

Solvay withdraws cilansetron NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Solvay has withdrawn its NDA for its irritable bowel syndrome agent cilansetron, the firm says Nov. 29. The company determined that "the amount of clinical work requested" as well as the potential IBS market for the 5-HT3 receptor antagonist suggested the company should focus on development of other compounds. Cilansetron was deemed "not approvable" March 23; FDA requested additional clinical trials to support an IBS indication for both women and men (Pharmaceutical Approvals Monthly April 2005, In Brief). Solvay said it is open to divesting cilansetron to another company...

You may also be interested in...



Solvay cilansetron "not approvable"

Solvay's irritable bowel syndrome therapy Calmactin (cilansetron) is "not approvable" March 23, one week ahead of the product's April 1 user fee date. FDA is requesting additional clinical trials to support an indication for treatment of IBS in both women and men. Solvay says it notified the agency March 30 of its intent to amend the cilansetron NDA. The decision follows the firm's February announcement that it no longer expected the Gastrointestinal Drugs Advisory Committee to review the 5-HT3 antagonist. The meeting was tentatively set for March 9 (1Pharmaceutical Approvals Monthly February 2005, p. 31)...

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

Topics

UsernamePublicRestriction

Register

ID1132956

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

Cancel