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

J&J Risperdal Consta “non-approvable”

Executive Summary

J&J will discuss FDA concerns about pre-clinical data for injectable long-acting antipsychotic Risperdal Consta (risperidone) following receipt of "non-approvable" letter. J&J filed the NDA Aug. 31, 2001...

You may also be interested in...



J&J Finalizing Risperdal Consta Resubmission; Approval Possible By Year-End

Johnson & Johnson is finalizing its response to a Risperdal Consta "not approvable" letter received from FDA last year

Alkermes Cutbacks Play Well On Wall Street; Biotech Model In Down Market?

Alkermes' August rebound on Wall Street suggests that the less-is-more approach is playing well with investors

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

UsernamePublicRestriction

Register

PS012935

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