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

Janssen hopes for Invega approval for the holidays

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The Johnson & Johnson subsidiary's NDA for the antipsychotic Invega (paliperidone extended-release) has a Dec. 20 user fee goal date, J&J said Nov. 10 after submitting a response to FDA's Sept. 29 "approvable" letter (1Pharmaceutical Approvals Monthly October 2006, In Brief)...

You may also be interested in...



J&J paliperidone ER "approvable"

Johnson & Johnson's extended-release schizophrenia agent paliperidone is "approvable" Sept. 29; J&J says it will "work quickly to resolve the agency's questions." Earlier in September, the company had indicated that it expected an approvable decision. J&J submitted the follow-on compound to its blockbuster atypical antipsychotic Risperdal (risperidone) in December 2005 (1Pharmaceutical Approvals Monthly December 2005, In Brief)...

EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

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.

Topics

UsernamePublicRestriction

Register

PS017586

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