Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 J&J Withdraws EMEA Submission for Comfyde | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

J&J Withdraws EMEA Submission for Comfyde

Johnson & Johnson has withdrawn an EMEA filing for Comfyde (carisbamate), its investigational drug being developed for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 or older.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Johnson & Johnson has withdrawn an EMEA filing for Comfyde (carisbamate), its investigational drug being developed for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 or older.

J&J’s Janssen-Cilag International unit notified the EMEA of its decision to withdraw the marketing authorization application based on the feedback from the EMEA’S Agency’s Committee for Medicinal Products for Human Use. The application was submitted to the agency in August.

The company also received a complete response letter from the FDA last August. No further details were provided.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters